statistics of scientific procedures on living animals
TRANSCRIPT
Statistics of Scientific Procedureson Living AnimalsGreat Britain2004
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HOME OFFICE
Statistics of
Scientific Procedures
on Living Animals
GREAT BRITAIN
2004
Presented to Parliament by the Secretary of State for the
Home Department
by Command of Her Majesty
December 2005
LONDON
HMSO
Cm 6713 £14.50 net
2
CONTENTS
PageINTRODUCTORY NOTES 4
MAIN POINTS 12
COMMENTARY 13
TABLES
(For an explanation of the terms used in the rows and columns of the tables,
see the Introductory Notes at pp. 5–11)
Explanatory flow chart 23
Part A Scientific Procedures: 2004
All procedures:
1 Scientific procedures by species of animal and primary purpose of the procedure 24
1a Animals by species of animal and primary purpose of the procedure 26
2 Scientific procedures by schedule 2 listed species and source of animals 28
2.1 As for table 2 but animals with harmful genetic defect only 29
2.2 As for table 2 but genetically modified animals only 30
3 Scientific procedures by species of animal, primary purpose and genetic status 31
3.1 Scientific procedures using genetically normal animals for production and breeding
of genetically modified or harmful mutant animal 35
3.2 Scientific procedures using harmful mutant animals in breeding procedures or research 36
3.3 Scientific procedures using genetically modified animals in breeding procedures or
research 37
4a Scientific procedures by species of animal and target body system 38
4b Scientific procedures by species of animal and level of anaesthesia 39
Non-toxicology:
5 Scientific procedures (non-toxicology) by species of animal and field of research 40
5a Animals (non-toxicology) by species of animal and field of research 44
5.1 As for table 5 but animals with harmful genetic defect only 48
5.2 As for table 5 but genetically modified animals only 49
6 Discontinued7 Discontinued8 Scientific procedures (non-toxicology) by species of animal and production and
breeding 50
9 Scientific procedures (non-toxicology) by species of animal and techniques of
particular interest 51
Toxicology:
10 Scientific procedures (toxicology) by species of animal and toxicological purpose 52
10a Animals (toxicology) by species of animal and toxicological purpose 56
11 Scientific procedures (toxicology) by species of animal, type of legislation and
toxicological purpose 60
12-16 Scientific procedures (toxicology) by species of animal and type of toxicological
test:
12 - all purposes 64
13 - safety testing of non-pharmaceuticals other than cosmetics 66
14 - this table discontinued because no procedures for cosmetics or ingredients in 200415 - pharmaceutical safety 67
16 - other safety/toxicology 68
17 Discontinued
3
Tree tables:
18a Procedures involving cats 69
18b Procedures involving dogs 70
18c Procedures involving horses and other equids 71
18d Procedures involving new-world primates 72
18e Procedures involving old-world primates 73
18f Procedures involving rabbits 74
18g Procedures involving genetically modified animals 75
18h Procedures involving animals with a harmful genetic defect 76
Part B Procedures, project licence holders and designated places: 2004
19 Project licence holders and scientific procedures by type of designated establishment 77
Part C Historical
20 Scientific procedures by species of animal, 1988-2004 78
21 Scientific procedures (toxicology) by type of legislation, 1995-2004 78
22 Scientific procedures by use of anaesthesia, 1988-2004 79
23 Scientific procedures by type of designated establishment, 1988-2004 79
24 Scientific procedures (non-toxicology) by field of research, 1995-2004 80
25 Scientific procedures (toxicology) for safety evaluation, 1992-2004 80
26 Scientific procedures by primary purpose, 1995-2004 81
27 Scientific procedures by primary purpose and genetic status, 1995-2004 81
APPENDIX A General System of control and the Inspectorate 82
APPENDIX B Return form - return of procedures by project for 2004, associated notes and
code lists 89
APPENDIX C Errata in 2003 published tables 101
Details of previous years’ publications 102
Feedback guidance 102
4
STATISTICS OF SCIENTIFIC PROCEDURES ON LIVING ANIMALS
GREAT BRITAIN 2004
INTRODUCTORY NOTES
1. The statistics in this publication relate to experiments or other scientific procedures on living animals that were
subject to the provisions of the Animals (Scientific Procedures) Act 1986 during the year from
1 January 2004. The system of control under the 1986 Act is explained in detail in Appendix A. Under this Act any
scientific procedure carried out on any living vertebrate animal, or one species of octopus (Octopus vulgaris), which is
likely to cause that animal pain, suffering, distress or lasting harm is a regulated procedure requiring licence authority.
Recognised veterinary, agricultural or animal husbandry practice and the administration of medicines under an Animal
Test Exemption granted under the Medicines Act 1968 are excluded from the controls of the 1986 Act. Statistics of
scientific procedures on living animals are collected and published annually. They are structured to comply with
European Union requirements, but the data provided are far more extensive than required by Europe.
Collection procedures
2. A return of scientific procedures is required each year from every person who holds a project licence for part
or all of the year. The statistics are compiled from a detailed form returned by project licence holders at the end of each
year, or on termination of the licence where this occurred during the year. A copy of the current form and the instructions
relating to its completion can be found at Appendix B. This return, completed by each project licence holder, provides
details of the species of animal used, the main purpose of the procedure and other details as described in paragraphs 12-
19 below. In these statistics each procedure (which may consist of several stages) for a given purpose on an animal is
counted as one returnable procedure for the year in which it commenced. A study involving a procedure using a number
of animals is counted once for each animal. Where an animal which has recovered fully from a completed procedure is
used again for a further procedure, this is counted as a separate procedure, but the animal itself is not re-counted. The
circumstances in which this re-use of an animal is permitted are limited.
3. Licence holders are required, as a condition of their licence, to submit a return even if no work has been
undertaken (nil returns). A list of licensees is drawn up at the end of the year prior to the start of the collection process,
and a record is kept of all licensees from whom returns have been received so that those who fail to make a return can
be reminded of their obligation under the Animals (Scientific Procedures) Act 1986. It is not always possible to obtain
every single return even though failure to submit is likely to result in the licence being revoked.
4. To ensure that the published data are as complete as possible the Home Office will not publish the statistics
unless the number of missing returns represents less than 0.5 per cent of all the returns expected, even though experience
has shown that the missing returns are likely to be nil returns.
5. Details of the work of individual project licence holders are not identifiable in this publication.
Accuracy
6. Verification and subsequent publication of these statistics are done by the Science and Research Group (SRG)
of the Home Office.
7. To complete the return, project licence holders are asked to classify their procedures according to a standard
coding list. The current classification system dates from 1995, and was modified in 1999 in those areas relating to source
of animals, production and breeding, toxicology and legislation. Fuller details are given in paragraphs 13, 14 (vii), 15,
16, 19 A (ii) and 19 B (ii) below. Licensees make returns by completing a form using specified codes. A full list of the
codes used can be found in the copy of the form, at Appendix B. During the collection and verification process, forms
that have been incorrectly coded are referred back to the licensees for correction. Incorrect coding might be either codes
which are wrong (i.e. outside the appropriate code range for the particular row) or which fail a cross-validation check
(i.e. where two codes in different rows are incompatible).
5
8. Throughout the collection process and right up to the point of publication, the Animals (Scientific Procedures)
Inspectorate (ASPI) scrutinise the returns and output tables to check that the returns are consistent with the terms of the
licences which have been granted. This is done by means of reports and tables, which are provided by SRG to ASPI.
During this period Inspectors may contact licensees to discuss and confirm coding, and inform SRG of any amendments
which may be necessary.
Description of statistical tables
9. Project licence holders are asked to answer 15 questions about the procedures performed (see form at Appendix
B), 12 of which identify individual characteristics explained more fully in paragraphs 12-19 below. The flowchart on
page 23 shows the relationship between the tables and the data in Part A.
10. Part B covers information on project licence holders, their place of employment and numbers of procedures.
11. Part C presents historical data for varying periods, depending on the table. For some tables, comparable figures
are available only from 1995 onwards.
References to previous years’ publications are given on the inside back cover.
PART A TABLES - PROCEDURES IN 2004
As a result of a review of the published tables in 2001, Tables 6, 7, 14 and 17 no longer appear. Although this leavesgaps in the table numbering, the existing numbering has been retained to preserve continuity from previous years. Thesequence of tables published in this year’s report is the same as that published since 2001.
Species of animal
12. All tables in Part A are classified by species of animal. The full classification is used in Tables 1, 1a, 5, 5a, 10
and 10a, but the other tables use a condensed classification. All the tables except 1a, 5a and 10a give the number of
procedures. Tables 1a, 5a, and 10a give the actual number of animals used for the first, and usually only, time in 2004
classified according to their first use. The list of species or categories of animals is selective to avoid undue
complications; when collective terms are used it is because previous experience suggests that the category will contain
a relatively small number or because further breakdown is of little interest. In several of the tables, rows which are
completely zero have been omitted and if a species is not mentioned it is because the row or rows pertaining to that
species is blank.
Genetic status of animal
13. Tables 2 (source), 3 (genetic status), and 5 (non-toxicological work by field of research) are subdivided to give
more information about animals with abnormal genetic constitutions. Table 2 shows procedures using all animals; Table
2.1 shows the number of procedures using animals with harmful (but naturally occurring) genetic defects and table 2.2
shows the number of procedures using genetically modified animals. Table 5 follows the same pattern. Table 3 is
subdivided into three supplementary tables (3.1, 3.2 and 3.3) to present in detail the use of normal animals, animals with
harmful mutations, and genetically modified animals respectively, in breeding programmes or research.
Primary purpose (Table 1)
14. The use of animals for regulated procedures is limited by section 5(3) of the Act to one of the following primary
purposes:
6
(i) fundamental biological research; carried out with the primary intention of increasing knowledge of
the structure, function and malfunction of man and other animals, or plants. Such studies may be
aimed solely at an increase in knowledge, application of that knowledge being beyond the scope of
the investigation, or with a view to providing a practical solution to a medical or veterinary problem
once the issues are more clearly defined and understood. This category includes physiological,
pathological, pharmacological, genetic and biochemical studies, including toxicological evaluation.
(ii) applied studies - human medicine or dentistry, and veterinary medicine; consisting of research
into, development of and quality control of products or devices, including toxicological evaluation
and safety or efficacy testing.
(iii) protection of man, animals or the environment; by toxicological or other safety or environmental
evaluation. This category is intended to cater for toxicological work which is not related either to
fundamental research or to the solution of medical and veterinary problems as such (see (i) and (ii)
above), but also includes some non-toxicological procedures. This category is further divided into a
number of subgroups (listed in Tables 10 and 10a). These are largely self-explanatory but the
following notes may be helpful in understanding the figures:
(a) while any one substance may be used in industry or in the home, or may
be an environmental pollutant, a herbicide or a pesticide, the project
licence holder classifies the procedure in accordance with the particular
context of the procedure and the expected primary use of the product;
(b) animal pesticides (as distinct from plant pesticides) are not included
amongst the types of substances listed, because a substance intended to
kill pests which infest or attack animals would be regarded as a
veterinary product. These are included in the appropriate body-system
group covered by primary purposes described in (ii) above;
(c) many of the procedures recorded under this category are required by
UK law or by the laws and regulations of countries in which it is
intended to use the substance concerned;
(d) the term ‘food additives’ covers substances deliberately added to food
as preservatives, artificial colourants or flavouring agents but not
studies on the nutritive value of food, accidental contamination or
infection of food, or medicines administered to animals or humans in
food.
(iv) education and training; these categories include procedures carried out under project licences for the
purposes of education or training under the 1986 Act. They also include killing of animals by methods
not included in Schedule 1 to the 1986 Act, if the killing takes place for educational purposes at a
designated establishment. Such killing may be authorised to provide, for example, tissues
subsequently used for education or training. The use of animals for the acquisition of manual skills is
currently permitted only for training in microvascular surgery, and at present this is always carried out
under general anaesthesia, without recovery.
(v) forensic enquiries; may refer to animal use in human or veterinary enquiries relevant to potential
legal proceedings.
(vi) direct diagnosis; investigation of disease including investigating suspected poisoning. This caters for
procedures carried out under the 1986 Act for the purpose of diagnosing disease in an individual
human or animal patient or a group of such patients. There is no research function: these are
essentially applied studies, predominantly involving the production of biological reagents, for
example antibodies and clotting factors.
7
(vii) breeding; a category for recording the production and breeding of animals with harmful genetic
defects, and genetically modified animals. The numbers recorded in this category include those
animals which are identified as possessing a harmful mutation or are genetically modified, but not
used subsequently on procedures which are recorded elsewhere in the tables. The numbers also
include some genetically normal animals which were subjected to regulated procedures such as tissue
sampling or hormonal administration for the purpose of regulated breeding programmes (see also
Tables 3, 3.1, 3.2, 3.3).
Source of animals (Tables 2, 2.1, 2.2)
15. Sections 7 and 10(3) of the Act require, unless a specific exemption is granted, that certain animals, listed in
Schedule 2 to the Act, be obtained from designated breeding or supplying establishments certified as such by the
Secretary of State. The species so listed during 2004 were: mouse, rat, guinea-pig, hamster, gerbil, rabbit, cat, dog,
ferret, primate and quail (Coturnix coturnix); also pigs (if genetically modified), and sheep (if genetically modified).
Normal pigs and normal sheep remain outside the scope of this schedule. The source of these species is tabulated
according to whether it is within the UK, within the remainder of the EU, within certain Council of Europe (but non-
EU) countries who are signatories to convention ETS 123, or elsewhere. Animals which originate from non-designated
sources, such as overseas breeding centres, but which are acquired by the project licence holder from a designated
supplying establishment in the UK, are reported under the heading “Animals acquired from other designated breeding
or supplying establishments in the UK.”
Table 2 lists numbers of procedures by source of animal, as described above; tables 2.1 and 2.2 list procedures by source
for animals with a harmful (but naturally-occurring) genetic defect, and genetically modified animals, respectively. In
columns 3–6 of these tables, use of Schedule 2-listed species from non-designated sources in the UK, or from Europe
or elsewhere, is subject to prior approval by the Home Office. Such use would be justified on the basis of scientific need
or lack of availability of appropriate animals from designated breeding or supplying establishments.
Stage of development, genetic status, and breeding (Tables 3, 3.1, 3.2, 3.3)
16. Stage of development
Details of procedures on animals in foetal, larval or embryonic form are collected but not shown in any of the
published tables because it may be impracticable in some cases to count such procedures, e.g. a foetus resorbed
during gestation, or fish fry which are very small and fast-moving.
Genetic status
Only the number of animals in which a harmful genetic defect actually manifested itself has been recorded for
spontaneously arising mutants. All genetically modified animals are recorded. Additional information on
counting animals in those categories is provided in Annex A at the end of Appendix B.
Table 3.1 shows the use of genetically normal animals in breeding programmes for both animals with harmful
mutations and genetically modified animals. The number of procedures is shown for: normal animals used to
generate founder genetically modified (GM) animals (which themselves will be further used in breeding
programmes), normal animals within GM breeding colonies, and normal animals within breeding colonies of
animals with naturally-occurring harmful mutations.
Tables 3.2 and 3.3 show the use of animals with harmful mutations and genetically modified animals
respectively in breeding programmes or research. The structure of these two tables is similar. They show,
respectively for harmful mutant and GM animals: procedures undertaken for maintenance of the breeding
colony (i.e. primary purpose is shown as “breeding” and row 11 is coded B64 or B62 as appropriate);
procedures undertaken for research analysis post mortem (primary purpose is not breeding, and row 11 coded
B64 or B62, as above); further regulated procedures, following on from the breeding programme (row 11 coded
B65 or B63); procedures used for production (row 11 coded B50–56); and procedures for toxicological (safety
evaluation) purposes (row 11 coded A30–50). For an explanation of these codes, see Appendix B at the end of
this publication.
8
Breeding
The breeding of animals with harmful genetic defects or genetically modified animals is a regulated procedure
under a project licence. Animals which are identified as ‘harmful mutants’ or ‘genetically modified’ may be
used for further breeding or used subsequently in procedures. The numbers also include some genetically
normal animals which were subjected to regulated procedures such as tissue sampling or hormonal
administration for the purpose of regulated breeding programmes.
The classifications of procedures concerned with breeding distinguish between:
(a) animals used to generate founder genetically modified animals for novel transgenic lines,
chimeras or clones;
(b) genetically modified animals generated by recognised husbandry methods for maintenance
of a breeding colony;
(c) genetically modified animals used in research programmes not concerned with breeding;
(d) animals with a harmful mutation generated by recognised husbandry methods for
maintenance of breeding colonies;
(e) animals with a harmful mutation used in research programmes not concerned with breeding.
Fuller details of these classifications will be found in Appendix B at List B, row 11.
Target body system (Table 4a)
17. Some of the headings in the tables are self-explanatory but, for the others, further explanation is given below.
Abbreviated title Description: studies in which interest centres on:
Nervous The central or peripheral nervous systems, other than the special senses
Senses Sight, hearing, smell, or taste
Alimentary The alimentary (including liver) and excretory systems
Musculo-skeletal The skeletal or muscle system
Immune and reticulo-endothelial The understanding and operation of the immune system
Other system A single body system not separately listed in the table
Multiple systems More than one system of primary interest
System not relevant The system or systems affected were not predictable or not relevant
Use of anaesthesia (Table 4b)
From the 2001 publication onwards, use of anaesthesia for both toxicological and non-toxicological procedures hasbeen combined into one simplified table. It replaced tables 7 and 17 of previous years’ publications.
18. The codes for anaesthesia distinguish procedures involving one or more stages in which there was anaesthesia
with recovery, from procedures in which the only anaesthesia was terminal. They also include the use of local or
regional anaesthesia. The categories are:
(a) no anaesthesia used throughout the procedure; this will include procedures without anaesthesia even
where the subject animal may have been killed by use of an anaesthetic overdose at the end of the
procedure. It also includes studies of potential anaesthetic agents;
(b) general anaesthesia with recovery;
(c) local or regional anaesthesia;
(d) general anaesthesia without recovery, at the end of the procedure only;
(e) general anaesthesia without recovery, throughout the procedure.
9
The killing of an animal by the administration of an overdose of an anaesthetic agent (a recognised humane
method as cited in Schedule 1 of the Act) is not a regulated procedure and is not recorded as such in the above
table.
The use of neuromuscular blocking agents (NMBA) is uncommon and for this reason such use is not shown in
the table (except as a footnote), but is described in the text.
Type of procedure
19. The tables are divided into two groups:
(a) fundamental and applied studies other than toxicology (Tables 5–9);
(b) toxicity tests, or other safety or efficacy evaluation (Tables 10–17).
If the purpose was non-toxicological, the licensee was asked to specify the field of
research, the nature of the procedure with regard to production and breeding and
whether the technique was identified as being of particular interest.
If the purpose of the procedure was toxicological, the licensee was asked to report
on the field of safety testing or efficacy evaluation, the type of test or procedure,
and the legislative requirements (if any) under which the procedure was performed.
The two strands of reporting are mutually exclusive (as shown in the flowchart and appendix B) and it is not
possible, for instance, to identify procedures using a technique of particular interest if the purpose of the
procedure was toxicological.
A Fundamental and applied studies other than toxicology
This group of tables is sub-divided into three main areas of interest:
(i) Field of research (Tables 5, 5a, 5.1 and 5.2)
The headings are self-explanatory, but the following should be noted:
(a) pharmaceutical research and development excludes anti-cancer agents, where work is listed
separately later in the table under ‘cancer research’;
(b) ecology excludes work done in toxicology and other safety evaluation;
(c) tobacco and alcohol research lists only those procedures done for research on the effects of
tobacco or alcohol, and not those where these substances are used as experimental tools or
standards; note also that tobacco safety procedures would be reported in table 10.
(ii) Production of biological materials (Table 8)
Production: procedures for production and maintenance of infectious agents (excluding those causing
neoplasms);
procedures for production and maintenance of vectors, e.g. parasites;
procedures for production and maintenance of neoplasms;
the ascites model for the production of monoclonal antibodies;
initial immunisation for subsequent in vitro or in vivo production of monoclonal antibodies;
procedures for production of polyclonal antibodies;
procedures for production of other biological material, e.g. plasma, tissues.
10
(iii) Techniques of particular interest (Table 9)
This table provides a selective list which identifies those procedures in which a technique is of itself
of particular interest as, for example, the application of a substance to the eye or exposure to ionising
radiation. The procedures recorded in this table do not include those undertaken for toxicology or
safety evaluation. However, few of these techniques would be used in routine regulatory toxicology
or safety assessments.
B Toxicity tests, or other safety or efficacy evaluation
(i) Safety and efficacy evaluation (Tables 10, 10a)
Most of the subdivisions have been described in paragraph 10 (iii) above with regard to general safety
or efficacy evaluation but the category also includes work done for pharmaceutical safety and efficacy
evaluation, and some other purposes as follows:
efficacy evaluation (acute, subacute and chronic);
absorption, distribution, metabolism, excretion (ADME) and residue tests;
nutritional evaluation;
quality control;
toxicology research;
tobacco safety (note: tobacco research is recorded in Table 5 – see above);
medical device safety;
method development, and other tests.
(ii) Legislative requirements (Table 11)
This identifies medical/dental and veterinary categories which include procedures used in the initial
development and selection of such products, those required to satisfy specific legislation (medical and
non-medical) such as the Medicines Act 1968 and/or equivalent overseas or international legislation
or regulations for purposes such as the intention of registration or the intention of presenting batch
quality control data; and those carried out for other reasons. The legislation is divided into seven
groups:
(a) United Kingdom legislation only;
(b) legislation specific to one EU country only (excluding the UK);
(c) general EU requirements, including the European Pharmacopoeia;
(d) non-EU member country of Council of Europe legislation;
(e) legislation of other countries;
(f) any combination of (a) – (e);
(g) purposes other than legislative requirements.
The following are examples of specific legislative requirements which may be included:
Medicines Act 1968;
Workplace safety, e.g. Health and Safety at Work Act 1974, COSHH Regulations;
Substances used in agriculture, e.g. Control of Pesticides Regulations 1986; EU Pesticides Directives;
Substances used in foodstuffs, e.g. Food Safety Act 1990.
(iii) Specific types of toxicity tests (Table 12)
acute and subacute dose ranging or limit setting lethal toxicity tests;
acute quantitative lethal toxicity tests;
acute and subacute non-lethal clinical sign toxicity tests;
subchronic and chronic toxicity tests;
carcinogen/teratogen/mutagen tests;
other reproductive toxicity tests;
tests for clinical signs in the eye;
tests for clinical signs on the skin, including irritation or sensitisation;
toxicokinetics, pyrogenicity, biocompatibility and other toxicology tests.
11
(iv) Tables showing some selected work in greater detail
There are three further tables which examine some aspects of toxicological work in greater detail (see appendix
B for full details of the codes):
Table 13: non-pharmaceuticals (list A, row 10, codes A01–A06);
Table 15: pharmaceuticals (list A, row 10, codes A11–A14);
Table 16: other safety or toxicology (list A, row 10, codes A21–A25).
(Table 14 on cosmetic safety has been discontinued since all such use ceased prior to 1999.)
Tree tables (Tables 18a-h)
20. These show, by means of ‘trees’, how procedures carried out on certain species of animals which are of
particular interest are broken down into their various categories. The species illustrated in this way are: cats, dogs,
horses, new-world primates, old-world primates, and rabbits. Two further tables were introduced in 1999 to illustrate
the use of genetically modified animals, and animals with harmful genetic defects.
PART B - PROJECT LICENCE HOLDERS AND DESIGNATED PLACES
Type of designated place (Table 19)
21. Project licence holders have been classified according to the type of designated place which was their main
place of employment at the end of the year, although they could be licensed to carry out procedures at more than one
place. Procedures have been classified according to the type of designated place of the project licence holder reporting
them.
PART C - HISTORICAL AND TIME-SERIES TABLES
22. Tables 20–27 summarise some selected aspects of the annual statistics collected since the introduction of the
Animals (Scientific Procedures) Act 1986 on 1 January 1987. For the reasons explained below, not all the tables refer
to the same time period.
23. Some of the historical tables which appeared in publications prior to 1995 have been discontinued because of
the lack of comparability with data for 1995 onwards, when the present system for collecting and presenting data was
introduced. Footnotes are given in those tables which have been retained to explain aspects of the discontinuities.
24. Two tables (21 and 25) have been adapted to reflect the way data have been reorganised: Table 21 carries
information about legislative requirements from 1995 only, because earlier data are no longer comparable, and Table 25
has replaced tobacco and alcohol safety data with data for pharmaceutical and other safety, but figures for earlier years
are still shown because in this case data in the rest of the table are comparable.
25. Three tables show data only from 1995: Table 24 on non-toxicology procedures by field of research, Table 26
on procedures by primary purpose, and Table 27 on procedures by primary purpose and genetic status. There are no
comparable figures for earlier years.
12
MAIN POINTS
1. The number of scientific procedures started in 2004 was just over 2.85 million, a rise of about 63,000
(2.3 per cent) on 2003.
2. Mice, rats and other rodents were used in the majority of procedures – 85 per cent of the total. Most of
the remaining procedures used fish (7 per cent), and birds (4 per cent).
3. Dogs, cats, horses and non-human primates, afforded special protection by the Act, were collectively
used in less than 1 per cent of the procedures. The number of such animals used for the first time rose
slightly from 9,100 in 2003 to 9,200 – mainly due to an increase in the use of dogs. Since 1995 there has
been a 28 per cent decrease in the combined use of these groups.
4. The number of procedures using non-human primates was 4,208, down 591 from 2003, a 12 per cent
fall; and with pharmaceutical R & D (research and development) and safety evaluation accounting for
3,157 (75 per cent) of the 2004 procedures. Since 1995 there has been a 31 per cent fall in the numbers
of primates used for the first time.
5. Over 99 per cent of procedures carried out on animals listed in Schedule 2 of the Act used animals
acquired from designated sources in the United Kingdom.
6. Genetically normal animals were used in 1,673,000 regulated procedures, a decrease of 76,000 (4 per
cent) from 2003. Their use represents 59 per cent of all procedures for 2004 (compared with 63 per cent
in 2003 and 84 per cent in 1995).
7. Species with harmful, but naturally-occurring, genetic mutations were used in 268,000 regulated
procedures, representing 9 per cent of all procedures for 2004. The majority of these were rodents (85
per cent).
8. Genetically modified animals were used in 914,000 regulated procedures representing 32 per cent of all
procedures for 2004 (compared with 27 per cent in 2003 and 8 per cent in 1995). The majority of these
were rodents (96 per cent).
9. Just under one third (32 per cent) of the genetically modified animals were used in scientific procedures
other than the maintenance of breeding colonies.
10. About 40 per cent of all procedures used some form of anaesthesia to alleviate the severity of the
interventions. For many of the remaining procedures the use of anaesthesia would have increased the
adverse effects of the procedure.
11. Non-toxicological procedures accounted for about 85 per cent of the procedures carried out in 2004, with
the main areas of use being for immunological studies, pharmaceutical research and development,
anatomy and cancer research. This contrasts with 75 per cent of procedures being for a non-toxicological
purpose in 1995.
12. Procedures for toxicological purposes accounted for 15 per cent of all procedures started in 2004; this
contrasts with 25 per cent of procedures being for a toxicological purpose in 1995 – an absolute decrease
of about 241,700 procedures.
13. About 70 per cent of toxicological procedures were for pharmacological safety and efficacy evaluation
in 2004.
14. About 80 per cent of toxicological procedures used rodent species. Non-human primates were used in
less than three quarters of one per cent of the toxicological procedures.
15. Eighty six per cent of toxicological procedures were performed to conform to legal or regulatory
requirements.
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COMMENTARY
OVERALL PICTURE
Procedures started in 2004
The number of scientific procedures started in 2004 was just over 2.85 million (Table 1), a rise of about
63,000 (2.3 per cent) compared to 2003. There has been a significant reduction in the annual number of
experiments or scientific procedures since 1976, this trend has levelled out in recent years but the figure
for 2004 was the highest since 1992. The overall level of scientific procedures is determined by a number
of factors, including the economic climate and global trends in scientific endeavour.
Some 2.78 million animals were used for the first time in procedures started in 2004 (Table 1a). This was
about 57,000 (2.1 per cent) more than in 2003, broadly reflecting the number of procedures started.
Figure 1: Experiments or procedures commenced each year, 1946-2004(1)
Species used (Tables 1 and 1a, Table 20 and Figure 2)
The species of animals involved in the largest numbers of procedures in 2004 were mice (67 per cent of
procedures), rats (16 per cent), fish (7 per cent), and birds (4 per cent). Domestic fowl accounted for
nearly 90 per cent of all birds used. These proportions are all broadly similar to those in recent years.
Dogs (0.28 per cent of all procedures in 2004), cats (0.03 per cent) and non-human primates (0.15 per cent)
were involved in relatively small numbers of procedures (a combined tota1 of 13,045 in 2004), and the total
use of these three groups fell by 90 procedures compared with the 2003 figure.
Despite the overall rise in the number of procedures in 2004, there were falls in procedures using most species
(see below), but the principal increase in 2004 was in procedures involving mice (up 102,500 – 6 per cent),
mainly due to their increased use in both fundamental and breeding procedures. Other species showing
increases on the 2003 figures were fish (up 20,600), amphibia (up 3,200), sheep (up 2,900), dogs (up 924),
hamsters (up 630) and mammals not separately categorised in the tables, (up 660).
0
1
2
3
4
5
6
Millions of procedures
(2) The experiments included in 1987’sfigures also counted as procedures under the 1986 Act
(1) Experiments under the 1876 Act or scientificprocedures under the 1986 Act
1946 1952 1956 1960 1964 1968 1972 1976 1980 1984 1988 1992 1996 2000 2004
Procedures (2)
Experiments
14
The increase in use of mice and fish in 2004 was mainly associated with breeding, but some of the rise was
also associated with fundamental biological research. The use of amphibia has increased mainly for the conduct
of fundamental studies. The rise in the use of sheep is mainly associated with applied research in veterinary
medicine. The use of dogs also rose, but numbers of procedures have fluctuated in recent years and the current
rise is within that general range, and was across all purposes. The large increase reported last year of some
6,500 procedures using quail (not C. coturnix) was reversed in 2004; such isolated short-lived increases in the
use of particular species occur from time to time and are usually related to a specific piece of research or other
scientific use.
There was a decrease in use of new world primates by about 15 per cent. The use of these species has
fluctuated in recent years, but there is a definite long-term downward trend. The number of procedures
involving old-world primates also decreased, by about 11 per cent, but the long-term trend in this case is
more difficult to determine since there have been marked fluctuations over the last ten years. Many
primates are re-used, since many of the procedures in which they are involved are of only mild effect, for
which anaesthesia is not required. Most of this work is for pharmaceutical research, development or safety.
In 2004 the ‘other carnivore’ category included badgers, mink and seals, all used for research relevant to
those species. The ‘other ungulate’ category, which appears only in some years, included only one
species in 2004, used for a single programme of work. The ‘other mammals’ included species such as
bats, marsupials and one type of shrew.
There were decreases in procedures using most species, but notably rats (down 31,000, or 6 per cent), rodents
other than mice or hamsters (down 10,000 or 22 per cent), rabbits (down 3,600, 14 per cent), cattle (down
2,550, 16 per cent), and fowl (down 8,300, 8 per cent). The decrease in use of non-Coturnix coturnix quail has
already been mentioned.
No procedures were performed in 2004 on greyhound dogs, camelids, prosimians, baboons, great apes,
gibbons, non-specified new-world primates and non-specified old-world primates, or Octopus vulgaris, the
single cephalopod species protected by the Act. The government stated in November 1997 that it would no
longer issue licences to use great apes in scientific procedures. No great apes have been used since the current
legislation (the 1986 Act) was introduced in 1987.
Where there was no use of a species, the species might not be listed in tables other than Tables 1, 1a, 5, 5a, 10
and 10a.
Figure 2: Procedures by species of animal and primary purpose of procedure, 2004
Primary purpose (Tables 1 and 1a, Tables 26 and 27, Figures 2 and 2A)
In 2004, the main purposes for performing scientific procedures were for breeding, fundamental biological
research, and applied studies into human medicine or dentistry. These accounted for 983,000 (34 per cent), 881,000
(31 per cent), and 672,000 (24 per cent) of the total number of procedures respectively.
Mice 67%
Rats 16%
Otherrodents1%
Other mammals 4%
Birds 4%
Reptiles/amphibians 1%
Fish 7%
Procedures by species Procedures by primarypurpose of procedure
Fundamentalbiologicalresearch 31%
Applied-humanmedicine24%
Protection4%
Breeding 34% Applied-veterinary medicine 5%
15
Breeding procedures accounted for much of the overall rise in procedures in 2004; see figure 2A. These
procedures were up 80,000 (part of a continuing rise). There were also rises in fundamental biological research
(up 48,000); procedures for this purpose have been fluctuating for a number of years, as have applied studies
into veterinary medicine, which rose by 5,700 or 4 per cent.
There was a further decline in procedures for the protection of man, animals or the environment (down 37,000,
25 per cent). Procedures for this purpose are now only just over half the level reported eight years ago.
Procedures for applied studies for human medicine were down 22,000 (3 per cent) on the 2003 figure; a steady
decline in this purpose seems to be flattening. Decreases were also reported for direct diagnosis of disease,
down 10,500 (19 per cent); an earlier decline halted and now annual figures for this purpose seem to be
fluctuating. The other purposes reported in Tables 1 and 1a recorded small falls, all in line with existing trends.
Figure 2A: Breeding, and other procedures, 1995-2004
Source (Tables 2, 2.1 and 2.2)
In 2004, 86 per cent of all procedures were performed on animals listed in Schedule 2 to the Act (mouse, rat,
guinea pig, hamster, gerbil, rabbit, cat, dog, ferret, non-human primate, pigs (if genetically modified), sheep (if
genetically modified), and quail (Coturnix coturnix)).
In total, 99 per cent (2.43 million) of procedures carried out on animals listed in Schedule 2 used animals
acquired from designated establishments in the United Kingdom, 60.5 per cent from the user’s own
establishment, and 39.5 per cent from another designated establishment. There is an established trend towards
using animals sourced from the licensee’s own establishment (rather than obtaining them from a designated
supplier), and the changes recorded in 2004 follow that trend. The number of procedures involving
Schedule 2 listed animals obtained from sources outside the EU in 2004 fell by 2,250 to 13,600 and of these,
almost all (13,340) were performed on animals obtained from outside Europe (68 per cent of which were mice).
Thirty six per cent of all procedures performed on non-human primates used animals acquired from designated
sources within the United Kingdom. Acquisition from abroad is due to a lack of available animals of either a
suitable strain or suitable health status for the particular purpose.
From Tables 2, 2.1 and 2.2, it can be seen that just under half of procedures on species listed in Schedule 2 that
were obtained from sources outside the UK, were performed on either harmful mutant or genetically modified
animals. They were almost all mice, and the remainder were rats. Three quarters of harmful mutant and 94 per
cent of genetically modified animals were obtained from within the licensee’s own designated establishment.
The use of animals in Schedule 2 acquired from non-designated sources in the UK was duly authorised as
properly justified under Section 10(3) of the Act. The rodents from non-designated sources in the UK are
mainly those involved in studies requiring animals from or in the wild.
The dogs from non-designated sources within the UK were ‘other dogs’, i.e. neither beagles nor greyhounds.
The research programmes required animals representative of the general pet population which are not available
2
3
Millions of procedures
Other procedures
Breeding2.5
1.5
1
0.5
01995 1996 1997 1998 1999 2000 2001 2002 2003 2004
16
from the usual designated sources, and which were used for studies relevant to the specific breed or type of
dog. There was a rise in 2004 of 169 procedures using imported dogs; this number tends to fluctuate from year
to year.
Some 399,000 procedures, up 6,100 (1.5 per cent) on 2003, were performed on species not listed in
Schedule 2. This number has shown fluctuations in recent years.
Genetic status (Tables 3, 3.1, 3.2, 3.3, Table 27, figure 2B)
Genetically normal animals (Tables 3, 3.1)
About 59 per cent of procedures started in 2004 involved normal animals, down 75,500 on 2003. In the longer
term, the use of genetically normal animals has decreased from 2.27 million in 1995 to 1.67 million, a drop of
26 per cent over this period. Table 3.1 shows normal animals used only in breeding programmes. Nearly all
these animals were mice (97 per cent), the remainder being rats, pigs, sheep, fish, birds, and amphibians.
Comparison with 2003 shows similar use to that year.
Animals with a naturally-occurring harmful genetic defect (Tables 3, 3.2)
Some 267,000 procedures (9 per cent of all procedures) started in 2004 involved animals with a naturally
occurring harmful genetic defect, 11,000 fewer than in 2003. Use of such animals has risen from 8 per cent of
all procedures in 1995 to just under 10 per cent now. The figures fluctuate slightly but there is a slight rising
trend. The animals used in 2004 were mostly mice (74 per cent), rats (11 per cent), and fish (14 per cent),
although there were a few procedures using other species. Other than procedures associated with maintenance
of breeding colonies, the work with mice and rats was split reasonably evenly between fundamental biological
research and applied studies (though rats tend to be used more for the latter). The fish and amphibia were bred
and/or used mainly for fundamental research. The procedures involving dogs were for studies of naturally-
occurring eye diseases relevant to those species, and man. The pattern of species use was very similar to that
in 2003. About 38 per cent of these animals were used for scientific purposes additional to breeding; fewer than
one half of one per cent were used in toxicology.
Figure 2B: Procedures involving normal, mutant, and genetically modified, animals, 1995-2004
Genetically modified animals (Tables 3, 3.3, Figure 2B)
The use of genetically modified (GM) animals was identified as a separate category for the first time in 1990;
this category accounted for some 914,000 procedures in 2004, 150,000 (32 per cent) more than in 2003. Nearly
a third of all procedures in 2004 involved genetically modified animals, and 96 per cent of these procedures
involved mice, most of the remainder being fish. Moreover, GM and mutant animals (see above) accounted for
over half of all mouse use (56 per cent) in 2004. There was an increase in GM mouse use across almost all
areas, while GM rat use rose slightly, reversing the decrease noted last year. Thirty seven GM pigs were used
(for breeding) in 2004, but no GM sheep use was noted. There was a decline in the number of procedures using
GM birds (fowl), but marked rises in the use of amphibians (up around 500, or 35 per cent), and fish, use of
which doubled from 16,000 last year to nearly 32,000 in 2004.
Millions of procedures
2.5
2
1.5
0.5
1
11995 1996 1997 1998 1999 2000 2001 2002 2003 2004
Normal animals
GM animals
Mutant animals
17
About 68 per cent of GM animals (623,000) were used solely to maintain breeding colonies, a similar
proportion to last year, and 30 per cent (278,000) were used for further scientific purposes. Fewer than one fifth
of one per cent were used in toxicology procedures. There was a decline in the generation of founder colonies
and in use of GM animals for toxicology, but rises for other purposes.
The regulated use of GM animals has more than quadrupled since 1995 and in percentage terms now represents
about 32 per cent of all scientific procedures, compared with 8 per cent in 1995. This increase has however
been offset by the decline in the use of genetically normal animals.
Target body system (Table 4a)
In 2004, about 56 per cent of all procedures were directed towards a particular body system. The largest single
category was the immune system, accounting for 18 per cent, or 509,000 procedures. The next largest was the
nervous system (14 per cent, 405,000 procedures). In both cases rodents were the main species used; in the
former case mainly mice, but in the latter case mice and rats were used in approximately equal numbers. There
were increases in use in 2004 for immune (up 21,000), respiratory (up 6,000), special senses (up 2,000) and
cardiovascular (up 700) systems. Other uses have fallen except for those categorized as relating to multiple
body systems or where a body system is not relevant. About 19 per cent of all procedures in 2004 were directed
towards more than one body system, and just over a quarter were procedures in which the body system was
not relevant.
Use of anaesthesia (Table 4b, Table 22)
Procedures are permitted without anaesthesia or analgesic only when the administration of an anaesthetic or
analgesic is judged to be more traumatic than the procedure itself, or when anaesthesia is incompatible with
the object of the procedure. Just under 60 per cent of procedures did not use anaesthesia. Local anaesthesia was
used in 312,000 procedures (almost the same number as in 2003, and about 11 per cent of the total), mainly in
mice (299,000 – usually for tissue collection for genetic analysis). Anaesthesia without recovery was used in
269,000 procedures, about 9.4 per cent of the total (up 3,100 from the year 2003).
Neuromuscular blocking agents (NMBA) were reported in 3,800 procedures, fewer than one in every 700
procedures, all of these in conjunction with general anaesthesia. About three quarters of these procedures were
carried out under general anaesthesia without recovery. Around 56 per cent of these procedures were performed
on rats, and much of the remainder on mice and other rodents.
FUNDAMENTAL AND APPLIED STUDIES OTHER THAN TOXICOLOGY, REGULATORY OR SAFETY
PURPOSES
The attention of readers is drawn to paragraph 15 of the introductory notes above where the method of recordingprocedures for toxicology and regulatory purposes, against those for non-toxicology purposes, is explained.
Some 2.42 million procedures, in which 2.35 million animals were used for the first time, were conducted for
purposes of fundamental and applied studies other than toxicology, safety or other regulatory purposes in 2004.
There was a rise of 75,000 in the number of such procedures and of 68,000 in the number of animals used,
compared with 2003, broadly reflecting the rise in the overall number of procedures. Although use of most
species fell, this was more than offset by the increases in the use of mice (up 90,000, mostly for breeding
purposes) and fish (up 24,000). Of the procedures started in 2004, 1.72 million (71 per cent) were performed
on mice and 330,000 (14 per cent) on rats; 98,000 (4 per cent) on birds (mainly domestic fowl) and 145,000
(6 per cent) on fish. A total of 2,300 procedures used dogs, just under 800 used cats and 1,040 used non-human
primates.
Field of research (Tables 5, 5a, 5.1 and 5.2, Table 24)
Of the various fields of research, the largest single category was immunology, which accounted for 484,000
procedures (20 per cent of all non-toxicology procedures, and up 62,000 or two percentage points on the 2003
figure), mainly on rodents, though a wide range of species was used. Pharmaceutical research and development
(393,000), cancer research (275,000) and anatomy (254,000) represented around 16, 11 and 10 per cent of the
total respectively. A range of species was used in pharmaceutical research; mice and rats accounted for all but
4 per cent of the procedures carried out for cancer research and rodents, fish and amphibia were the main
species used for anatomy research. Physiology and genetics were the only other fields where the number of
procedures was greater than 5 per cent of all non-toxicology procedures.
18
The main changes compared with 2003 were: anatomy (up 26,000, an 11 per cent rise, following a rising trend);
biochemistry (up 7,600), immunology (up 62,000, continuing a rising trend), clinical medicine (up 7,300, or
64 per cent), genetics (up 21,000, a strongly rising trend), molecular biology (up 17,000), and nutrition (up 6,900).
There were several smaller rises in other disciplines. Decreases were reported in procedures for physiology (down
16,000 or 8 per cent, but within a rising trend), pathology (down 9,500), microbiology (down 13,400),
parasitology (down 20,000, a drop of 18 per cent, continuing the fall from a peak in 2002), and animal science
(down 13,000, reversing the rise in 2003). No procedures were carried out for research on the effects of tobacco;
there has been no research of this kind since 2001.
Animals with harmful genetic defects (Table 5.1) were used across a wide range of disciplines, but none were
used for dentistry, zoology, botany, animal science, ecology, or research related to the use of tobacco or alcohol.
The principal disciplines for which such animals were used were: cancer research (88,000 or a third of all
procedures involving animals with harmful mutations); anatomy (50,000, or 19 per cent); immunology (27,000
or 10 per cent); genetics (26,400, 10 per cent), and ‘other’ use (i.e. disciplines not otherwise specified), 34,600 or
13 per cent. Mice, rats and fish were the main species used.
There was a broadly similar spread of disciplines involving genetically modified animals (Table 5.2). The
greatest use was for immunology (270,000 or 30 per cent of procedures using GM animals), cancer research
(107,000 or 12 per cent) and anatomy, which includes developmental biology (127,000 or 14 per cent).
Procedures for all disciplines showed increases from 2003 except for psychology, parasitology, clinical
medicine and animal science. No procedures using GM animals were performed for the disciplines of dentistry,
clinical surgery, zoology, botany, ecology, or tobacco research.
Production of biological materials (Table 8)
In 2004 some 286,500 procedures, 15,000 more than in 2003, were performed for the purposes of production
of biological materials. Of these, about 30 per cent were for the production of infectious agents and, of this
particular group, 63 per cent used birds and a further 32 per cent used mice. Vectors, neoplasms and polyclonal
antibodies accounted for a further 12 per cent; here, rodents were the main animals used except for polyclonal
antibody production, where a wider range of species was used. The remaining 56 per cent of production
procedures were to obtain other biological material such as tissues or blood products, also using a wide range
of species.
In November 1997, the Government confirmed that the production of monoclonal antibodies by the ascites
method could only be considered if in vitro attempts at production had failed, or the use of animals was justified
for specific diagnostic or therapeutic products. The coding of the returns form was changed in 1999 to
distinguish between procedures for the immunisation of animals used in monoclonal antibody production, (for
which there are no generally applicable replacement alternatives), and those where the ascites model has been
used. The immunisation method to produce tissues for in vitro use (using mostly mice) showed a drop of 970
to 3,400. No procedures have been performed since 2001 using the ascites model.
Techniques of particular interest (Table 9)
Among non-toxicological work, certain procedures have been identified as being of particular interest. These
have been described above in paragraph 15A(iii) of the introductory notes. About 159,000 procedures,
representing 7 per cent of non-toxicological procedures, fell into this category in 2004, about 4,250 fewer than
the number reported in 2003. The general trend is downwards since this category of procedure was separately
identified in 1995, but the trend has flattened since around 2000. There were some increases, principally in
procedures involving interference with the organs of special sense (up 4,000). There were also decreases,
including procedures involving injection into the brain (down 4,000), psychological stress (down 7,600), and
inhalation (down 6,000). Physical trauma procedures used mainly rodents, and included work for pain and
other neuronal injury studies, tissue repair studies, and atheroscelerosis. Aversive training mainly involved
mice, rats and birds. The thermal injury category included mainly tissue repair studies.
TOXICOLOGY OR OTHER SAFETY OR EFFICACY EVALUATION
(Tables 10, 10a, 21, 25 and Figure 3)
Procedures for the purpose of toxicology or safety and efficacy evaluation accounted for 435,500, or just over
15 per cent, of the total number of procedures carried out in 2004. This was about 12,000 fewer than in 2003.
The decrease was reflected in a similar fall (10,750) in the number of animals used for the first time, which in
2004 was 425,200. Toxicology procedures continue to form an ever smaller proportion of scientific procedures
overall; in 2004 they represented only 15 per cent, compared with 25 per cent in 1995.
19
Species
Of toxicology procedures started in 2004, 202,000 (46 per cent) used mice; a further 135,000 (31 per cent) used
rats, and other rodents were used in 12,100 procedures (3 per cent). Some 49,500 (11 per cent of the total) used
fish; 16,100 used rabbits; birds were used in 7,500 procedures, and dogs (beagles) in 5,800. Other species
accounted for just under 2 per cent of all toxicology procedures; 3,200 used non-human primates (principally
old-world species) but only 26 used cats. Species for which there was a fall in the number of toxicological
procedures in 2004 included: rats (down 8,500, or 6 per cent); guinea pigs (down 2,400), rabbits (down 1,400),
old world monkeys (down 480), birds (down 11,000) and fish (down 3,300). There were some species with an
increase in use: the main instance was procedures on mice which rose 12,400, or 6.5 per cent; also dogs (up
730), sheep (up 170), cattle (up 170) and new world monkeys (up 100). There was actually an overall decrease
of 169 in the number of individual non-human primates used for the first time, a decrease of 261 in old world
monkeys being offset by an increase of 92 in new world monkeys. As in previous years, the non-human
primates, dogs and cats were used mainly for pharmaceutical safety.
Figure 3: Procedures (toxicology) by species of animal, purpose of test, legislative requirement and type of test,2004
Only 1,548 procedures involving genetically modified animals were carried out for toxicology, and all the
animals so used were mice (see Table 3.3). This represents just over one in 600 of all genetically modified
animals used, and is somewhat less than the proportion reported a year ago. There were 1,010 procedures for
toxicology involving animals with harmful genetic defects (all mice); this represented about one procedure in
every 270 involving these animals, about the same proportion as last year (Table 3.2).
Mouse 46%Guineapig 2%
Fish 11%
Bird 2%
Rabbit 4%
Other 4%
Rat 31%
Species of animal
PharmaceuticalSafety 33%
Environmental andother safety 21%
Otherpharmaceutical 29%
Purpose of test
Legislative requirement
Non-legislative 14%
UK alone 4%Jointrequirements69%
Other international 3%
EU 10%
Type of test
Acute lethal 24%
Acute limit-setting 4%
Acute non-lethal 4%
Subacute and chronic 15%
Other specific 26%
Other non-specific 27%
Pharmaceuticalefficacy 8%
Other toxicology 8%
20
Purposes
Pharmaceutical safety, efficacy evaluation, residue studies and quality control accounted for 70 per cent of
toxicology procedures in 2004. The next most common purposes were safety evaluation of substances used in
industry (8 per cent), in agriculture (6.5 per cent), and evaluation of environmental pollution (7 per cent).
Decreases were reported in some types of procedures, but particularly those concerned with the safety of
substances used in agriculture (down 12,000), pharmaceutical efficacy testing (down 8,200, following a long-
term declining trend) and, to a lesser extent, foodstuffs and additives (down 7,200), toxicology research (down
4,250, following a slowly declining trend), non-specific toxicology (down 3,100), and procedures connected
with environmental pollution (down 3,800). A few categories showed a rise in the number of procedures; those
for pharmaceutical quality control were up 14,000 (18 per cent on 2003); pharmaceutical safety testing (up
13,000), and pharmaceutical ADME and residue testing, up 4,700. Except where stated in this paragraph, most
of the movements are within fluctuations noted over the last ten years.
In November 1997 the Government announced that no further licences would be issued for cosmetic finished-
product testing, and that existing licences had been amended to exclude this type of work. This was extended in
November 1998 to ingredients intended primarily for cosmetics. As a consequence no procedures were performed
for either of these purposes in 2004. Since 1995 there has been no safety testing of tobacco or tobacco products and
there are no licences in force authorising procedures of this kind.
Legislative requirements (Table 11, Table 21, Figure 3)
Of the total of 436,000 toxicology or safety procedures in 2004, 86 per cent were performed to comply with
legislation or other regulations. Only 19,800 procedures (4 per cent) were performed to satisfy UK legislation
alone, the slight fall following the prevailing general downward trend; about 43,700 (10 per cent – see pie chart
in Fig. 3) were performed to satisfy the requirements of either a single EU country (excluding the UK) or the
EU in general; and 14,600 (3 per cent) for other international legislation. The majority of procedures performed
to fulfil legislative requirements (300,000, or 69 per cent) were used to satisfy a combination of the above
requirements. The remaining 59,000 procedures, 14 per cent of toxicology and safety work (a fall of 15,000
procedures from 2003, reversing the rise noted last year, and continuing the general downward trend), were
performed for purposes other than direct legislative or regulatory requirements.
Type of test (Tables 12, 13, 15, 16, Figure 3)
See explanatory notes for List A, Row 11 in Appendix C for more details of the type of test or procedure.
From 1999 the category of procedures relating to acute lethal toxicity tests was subdivided into: acute lethal
(LD50), acute lethal concentration (LC50) and other types of acute limit-setting tests. In 2004 acute
quantitative lethal toxicity tests accounted for 84,000 procedures or 19 per cent of all toxicology work. Tests
were reported in this category for the following purposes: pharmaceutical efficacy; pharmaceutical quality
control; method development; non-specific toxicity tests; and a smaller number of procedures for the safety of
substances in agriculture and industry, and for toxicology research. Very nearly all these procedures used mice.
None of these procedures were LD50 tests carried out according to the previous OECD Guideline 401. The
acute lethal toxicity tests involved testing of biopharmaceuticals including veterinary biologicals, and food
safety tests. Acute lethal concentration tests accounted for 20,100 procedures (5 per cent of all toxicology), and
acute limit-setting lethal toxicity tests another 18,700 procedures (4 per cent). There was an overall decrease
in the use of procedures for acute safety testing from 144,000 in 2003 to 138,000 in 2004, but numbers of
individual types of test have tended to fluctuate in recent years.
A further 43,400 procedures (10 per cent of toxicology procedures) were carried out for subacute limit-setting
or subacute toxicity tests. This was 5,200 more than in 2003. Of the remaining tests, other, non-specified,
toxicological tests (in which a wide range of species was used, with the majority being mice, rats and other
rodents) accounted for the greatest single proportion with 117,600 procedures (27 per cent of the total), a rise
of about 2,800 on 2003. The present ‘other’ category is comprised mostly of procedures concerning
pharmaceutical safety testing not otherwise described, other basic or applied toxicology research, and the
acquisition of tissues for further in vitro studies.
21
There were about 8,500 procedures carried out on rabbits for pyrogenicity testing which will continue as a
necessary safety test required by regulatory bodies as there is no validated alternative for the evaluation of non-
crystalloid substances for intravenous injection into humans; a further 800 procedures were carried out on
rabbits to test for clinical signs in the eye (300 fewer than in 2003); 27,000 procedures (almost half the number
reported last year), of which 85 per cent were on rats, to test for reproductive toxicity; and 2,700 procedures
on rodents to test for skin sensitization, mainly on mice and guinea pigs used for the safety testing of products
used in agriculture and industry. Procedures for skin sensitisation tests were down 75 per cent from 2003.
Further detailed analysis of safety testing is contained in Tables 13, 15 and 16. Each of these tables takes one
of the three purposes shown in the columns in Table 11, and examines procedures by species by each of the
types of test shown in the columns of Table 12. For example, Tables 13, 15 and 16 show that the 23,100
procedures carried out on rats for reproductive toxicity other than teratogenic testing (Table 12) is split mainly
between safety testing of pharmaceuticals (see Table 15), and non-pharmaceuticals (Table 13), with
comparitively few on other safety and toxicity testing (Table 16).
Two of these three tables show a fall in the number of procedures against the comparable figures for 2003:
environmental and industrial safety down 25,200, other safety down 10,500, but pharmaceutical safety up
23,500.
Rodenticide trials
It is impractical to collect accurate figures on the number of animals affected in field trials of rodenticidal
substances. No field trials were reported to have been started in 2004.
Use of animals in CITES list
Returns were required on the use of animals listed in Appendix 1 of the Convention on International Trade in
Endangered Species of Flora and Fauna (CITES) or in Annex C.1 to the Council Regulation (EEC)3626/82
(see the notes to the return form in Appendix C). There were 47 procedures performed in 2004 on animals in
this category, all on wild birds.
TREE TABLES (Tables 18a-h)
These tables show the relationship between the purpose of the procedures and the target body system for six
species in which there is special interest (Tables 18a-f). The species presented in these tables are: cats, dogs,
horses, new-world (non-human) primates, old-world (non-human) primates, and rabbits. Two further tables
illustrate the use of genetically modified animals (Table 18g) and animals with a harmful genetic defect (Table
18h). Additional information on use is provided where appropriate.
RETURNS, PROJECT LICENSEES AND DESIGNATED PLACES
Figure 4: Project licence holders and procedures started in 2004, by type of designated place (note: only those project
licence holders reporting procedures in 2004 are included)
Universities 68%
Government4%
Non-profit 4%
Other public 12%
Commercial 13%
Project licence holders Procedures
Universities 42%
Gov’t 2%
Non-profit 5%
Other public 17%
Commercial 33%
22
Returns (Table 19)
Returns were received in respect of 3,550 project licences in 2004. Returns were received from all but a very
few licensees. Just under 2,600 licensees reported starting procedures in 2004, some 250 fewer than in 2003.
Of these, about 2,000 (77 per cent, similar to the proportion in 2003), reported starting more than 50
procedures. The holders of about 950 project licences (27 per cent of all licensees) reported starting no
procedures in 2004 (Table 19). This was also very similar to the position in 2003.
Figure 5: Procedures by type of establishment, 1987-2004. The graph shows the two types of institution responsiblefor the largest number of procedures (and therefore that have most impact on the overall number of proceduresstarted each year).
Project licensees and designated places (Table 19, Table 23, Figures 4 and 5)
Sixty eight per cent of the projects on which procedures were started in 2004 were based at universities or other
academic establishments (including medical schools) but they accounted for only just over 42 per cent of the
number of procedures. Projects at commercial organisations accounted for almost exactly a third of procedures
started in 2004 (down three percentage points on 2003) but represented only an eighth of the total number of
active projects.
Throughout the period 1981 to 1992 university licensees performed between one-fifth and one-quarter of all
experiments or procedures, but since 1992 this has slowly risen to over 42 per cent. The proportion of
procedures carried out by commercial licensees has fallen from 60 per cent in 1987 to 33 per cent in 2003
(Table 23; see also Figure 5). The number of procedures reported by universities or other higher educational
establishments overtook that reported by commercial organisations for the first time in 2000, and is now clearly
ahead (see Figure 5).
The fall in the number of procedures carried out by commercial licensees was largely responsible for the
overall fall in the total number of procedures until a few years ago, but the rise in the number of procedures
conducted in universities and non-governmental public bodies clearly contributed to the overall rise in the
number of procedures in 2004 (see Table 23). The number of procedures started in public health laboratories
has tended to fall in recent years, as have those in NHS hospitals (many of the latter are classified as university
departments for the purposes of these statistics). There is an overall rising trend in procedures conducted in
non-governmental public bodies, but a recent rise in procedures reported by the not-for-profit sector appears to
have peaked in 2001, although the overall trend is still very slightly upwards.
Historical tables
Tables 20-27 (q.v.) show longer-term trends in scientific procedures.
Millions of procedures
4
3.5
2.5
1.5
0.5
2
3
1
1987 20041992 1996 2000
Total
Universities
Commercial
23
Organisation Chart: Relationship between the tabels in part A, 2004
TABLE 1
Species by purpose(procedures)
TABLE 1a
Species by purpose(animals)
TABLES 2.1, 2,2
Source by genetic status:harmful defects, GM
TABLES 3.1, 3.2, 3.3
Breeding procedures andresearch by genetic status
TABLE 2
Source of animals
TABLE 3
Genetic status
TABLE 4a
Target body system
TABLE 4b
Anaesthesia
TABLE 10
Field of toxicology(procedures)
TABLE 11
Legislative requirements
TABLE 12
Type of test – overall
TABLE 13
Type of test – safety
TABLE 10a
Field of toxicology(animals)
TABLES 5.1, 5.2
Field of researchby genetic status:
harmful defects, GM
TABLE 8
Production ofbiological materials
TABLE 15
Type of test – safetyof pharmaceuticals
TABLE 16
Type of test –other toxicology
TABLE 9
Techniques of interest
TABLE 5a
Field of research(animals)
TABLE 5
Field of research(procedures)
(Toxicology) (Non-toxicology)
NotesTree tables and tables in parts B and C are separate from this relationship.GM = genetically modifiedTables 6, 7, 14, and 17 have been discontinued as being either superfluous or having been superseded by other tables.
Detailed descriptions of the terms used in the tables will be found in the Introductory Notes, at page onwards.
Tabl
e 1
Scie
ntifi
c pr
oced
ures
by
spec
ies
of a
nim
al a
nd p
rimar
y pu
rpos
e of
the
proc
edur
e
Gre
at B
ritai
n 20
04N
umbe
r of p
roce
dure
sS
peci
es o
f ani
mal
Prim
ary
purp
ose
of th
e pr
oced
ure
Tot
al
Fund
amen
tal
biol
ogic
al
rese
arch
App
lied
stud
ies
-hu
man
m
edic
ine
or
dent
istry
App
lied
stud
ies
-ve
terin
ary
med
icin
e
Pro
tect
ion
of
man
, ani
mal
s or
en
viro
nmen
t
Edu
catio
nTr
aini
ngFo
rens
ic
enqu
iries
Dire
ct
diag
nosi
sB
reed
ing
Mam
mal
Mou
se60
1,32
735
0,63
424
,491
24,5
9997
1-
-7,
539
909,
577
1,91
9,13
8 R
at12
6,52
426
7,40
21,
086
44,2
9356
186
3-
340
23,6
5846
4,72
7 G
uine
a pi
g2,
751
22,2
971,
404
217
140
--
292
-27
,101
Ham
ster
2,32
82,
298
410
--
--
--
5,03
6 G
erbi
l1,
775
1,92
7-
--
--
--
3,70
2 O
ther
rode
nt1,
431
-11
491
--
--
-1,
636
Rab
bit
1,86
913
,209
2,11
82,
534
61-
-1,
728
217
21,7
36 C
at20
7-
612
--
--
--
819
Dog
B
eagl
e12
07,
027
261
147
--
-24
4-
7,79
9
Gre
yhou
nd-
--
--
--
--
-
Oth
er in
clud
ing
cros
s-br
ed d
ogs
217
191
--
--
--
219
Fer
ret
169
828
2-
13-
-26
-1,
038
Oth
er c
arni
vore
601
-15
276
--
--
-82
9 H
orse
, don
key
and
cros
s-br
ed e
quid
s35
6-
280
516
-40
7,82
0-
8,51
7 P
ig2,
923
525
5,75
910
717
--
1,79
853
11,1
82 G
oat
322
4324
4-
--
2-
395
She
ep6,
670
567
13,1
41-
5-
320
,868
2941
,283
Cat
tle3,
439
210
,156
191
--
3-
13,6
20 D
eer
132
-14
--
--
--
146
Cam
elid
--
--
--
--
--
Oth
er u
ngul
ate
--
-3
--
--
-3
Prim
ate
P
rosi
mia
n-
--
--
--
--
-
New
Wor
ld m
onke
y
m
arm
oset
, tam
arin
239
747
--
--
-9
-99
5
S
quirr
el, o
wl,
spid
er m
onke
y-
40-
--
--
--
40
O
ther
New
Wor
ld m
onke
y-
--
--
--
--
-
24
Tabl
e 1
Scie
ntifi
c pr
oced
ures
by
spec
ies
of a
nim
al a
nd p
rimar
y pu
rpos
e of
the
proc
edur
e (C
ontin
ued)
Gre
at B
ritai
n 20
04N
umbe
r of p
roce
dure
sS
peci
es o
f ani
mal
Prim
ary
purp
ose
of th
e pr
oced
ure
Tot
al
Fund
amen
tal
biol
ogic
al
rese
arch
App
lied
stud
ies
-hu
man
m
edic
ine
or
dent
istry
App
lied
stud
ies
-ve
terin
ary
med
icin
e
Pro
tect
ion
of
man
, ani
mal
s or
en
viro
nmen
t
Edu
catio
nTr
aini
ngFo
rens
ic
enqu
iries
Dire
ct
diag
nosi
sB
reed
ing
O
ld W
orld
mon
key
Mac
aque
762,
521
-57
5-
--
1-
3,17
3
B
aboo
n-
--
--
--
--
-
O
ther
Old
Wor
ld m
onke
y-
--
--
--
--
-
Ape
Gib
bon
--
--
--
--
--
Gre
at a
pe-
--
--
--
--
- O
ther
mam
mal
2,27
239
-82
--
--
-2,
393
Bird
Dom
estic
fow
l (G
allu
s do
mes
ticus
)21
,607
210
68,3
661,
571
--
-1,
712
565
94,0
31 T
urke
y1,
401
5028
2-
--
-19
4-
1,92
7 Q
uail
(Cot
urni
x co
turn
ix)
70-
--
--
--
-70
Qua
il (s
pp.o
ther
than
Cot
urni
x co
turn
ix)
60-
-50
6-
--
--
566
Oth
er b
ird7,
489
-37
118
2-
--
670
-8,
712
Rep
tile
Any
rept
ilian
spe
cies
521,
294
-8
--
--
-1,
354
Am
phib
ian
Any
am
phib
ian
spec
ies
16,0
29-
-61
396
3-
--
590
18,1
95Fi
sh A
ny fi
sh s
peci
es78
,637
270
27,1
5438
,449
--
-2,
101
47,9
5119
4,56
2C
epha
lopo
dO
ctop
us v
ulga
ris-
--
--
--
--
-
Tota
l88
0,89
767
1,93
715
6,38
811
4,08
12,
748
863
4345
,347
982,
640
2,85
4,94
4
25
Tabl
e 1a
Ani
mal
s by
spe
cies
of a
nim
al a
nd p
rimar
y pu
rpos
e of
the
proc
edur
e
Gre
at B
ritai
n 20
04N
umbe
r of a
nim
als
Spe
cies
of a
nim
alP
rimar
y pu
rpos
e of
the
proc
edur
e T
otal
Fu
ndam
enta
l bi
olog
ical
re
sear
ch
App
lied
stud
ies
-hu
man
m
edic
ine
or
dent
istry
App
lied
stud
ies
-ve
terin
ary
med
icin
e
Pro
tect
ion
of
man
, ani
mal
s or
en
viro
nmen
t
Edu
catio
nTr
aini
ngFo
rens
ic
enqu
iries
Dire
ct
diag
nosi
sB
reed
ing
Mam
mal
Mou
se59
3,88
035
0,32
924
,491
24,5
9997
1-
-7,
539
908,
301
1,91
0,11
0 R
at12
4,84
726
1,33
31,
086
44,2
9356
186
3-
340
23,6
5845
6,98
1 G
uine
a pi
g2,
751
22,1
861,
404
217
140
--
264
-26
,962
Ham
ster
1,87
62,
298
410
--
--
--
4,58
4 G
erbi
l1,
727
1,92
7-
--
--
--
3,65
4 O
ther
rode
nt1,
431
-11
491
--
--
-1,
636
Rab
bit
1,62
27,
195
1,44
92,
514
54-
-1,
661
217
14,7
12 C
at19
1-
307
--
--
--
498
Dog
B
eagl
e99
4,91
123
714
1-
--
88-
5,47
6
Gre
yhou
nd-
--
--
--
--
-
Oth
er in
clud
ing
cros
s-br
ed d
ogs
217
66-
--
--
-94
Fer
ret
169
818
2-
13-
-17
-1,
019
Oth
er c
arni
vore
601
-14
668
--
--
-81
5 H
orse
, don
key
and
cros
s-br
ed e
quid
s66
-17
35
16-
-79
-33
9 P
ig2,
906
477
5,48
510
717
--
1,79
753
10,8
42 G
oat
291
4324
3-
--
2-
363
She
ep6,
431
553
13,0
76-
5-
346
629
20,5
63 C
attle
2,49
9-
3,26
219
1-
-3
-5,
784
Dee
r13
2-
14-
--
--
-14
6 C
amel
id-
--
--
--
--
- O
ther
ung
ulat
e-
--
3-
--
--
3 P
rimat
e
Pro
sim
ian
--
--
--
--
--
N
ew W
orld
mon
key
mar
mos
et, t
amar
in22
851
0-
--
--
9-
747
Squ
irrel
, ow
l, sp
ider
mon
key
--
--
--
--
--
Oth
er N
ew W
orld
mon
key
--
--
--
--
--
26
Tabl
e 1a
Ani
mal
s by
spe
cies
of a
nim
al a
nd p
rimar
y pu
rpos
e of
the
proc
edur
e (C
ontin
ued)
Gre
at B
ritai
n 20
04N
umbe
r of a
nim
als
Spe
cies
of a
nim
alP
rimar
y pu
rpos
e of
the
proc
edur
e T
otal
Fu
ndam
enta
l bi
olog
ical
re
sear
ch
App
lied
stud
ies
-hu
man
m
edic
ine
or
dent
istry
App
lied
stud
ies
-ve
terin
ary
med
icin
e
Pro
tect
ion
of
man
, ani
mal
s or
en
viro
nmen
t
Edu
catio
nTr
aini
ngFo
rens
ic
enqu
iries
Dire
ct
diag
nosi
sB
reed
ing
O
ld W
orld
mon
key
Mac
aque
601,
590
-39
4-
--
1-
2,04
5
B
aboo
n-
--
--
--
--
-
O
ther
Old
Wor
ld m
onke
y-
--
--
--
--
-
Ape
Gib
bon
--
--
--
--
--
Gre
at a
pe-
--
--
--
--
- O
ther
mam
mal
2,27
239
-74
--
--
-2,
385
Bird
Dom
estic
fow
l (G
allu
s do
mes
ticu s
)21
,042
210
68,3
661,
571
--
-1,
710
565
93,4
64 T
urke
y1,
401
628
2-
--
-29
-1,
718
Qua
il (C
otur
nix
cotu
rnix
)70
--
--
--
--
70 Q
uail
(spp
,oth
er th
an C
otur
nix
cotu
rnix
)60
--
506
--
--
-56
6 O
ther
bird
7,39
7-
315
182
--
-66
0-
8,55
4R
eptil
e A
ny re
ptili
an s
peci
es52
22-
8-
--
--
82A
mph
ibia
n A
ny a
mph
ibia
n sp
ecie
s8,
836
--
609
963
--
-52
110
,929
Fish
Any
fish
spe
cies
78,6
3727
027
,126
38,4
49-
--
2,09
646
,973
193,
551
Cep
halo
pod
Oct
opus
vul
garis
--
--
--
--
--
Tota
l86
1,59
565
4,72
414
7,83
511
3,85
32,
741
863
316
,761
980,
317
2,77
8,69
2
27
Tabl
e 2
Scie
ntifi
c pr
oced
ures
by
Sche
dule
2 li
sted
spe
cies
and
sou
rce
of a
nim
als
Gre
at B
ritai
n 20
04N
umbe
r of p
roce
dure
s
Spe
cies
of a
nim
alS
ourc
eTo
tal
Ani
mal
s ac
quire
d fro
m w
ithin
ow
n de
sign
ated
es
tabl
ishm
ent
Ani
mal
s ac
quire
d fro
m a
noth
er
desi
gnat
ed
bree
ding
or
supp
lyin
g es
tabl
ishm
ent i
n th
e U
K
Ani
mal
s ac
quire
d fro
m n
on-
desi
gnat
ed s
ourc
es
in th
e U
K
Ani
mal
s ac
quire
d fro
m s
ourc
es w
ithin
th
e E
U (o
utsi
de th
e U
K)
Ani
mal
s ac
quire
d fro
m C
ounc
il of
E
urop
e co
untri
es
who
are
sig
nato
ries
to E
TS12
3
Ani
mal
s ac
quire
d fro
m o
ther
sou
rces
Ani
mal
s no
t lis
ted
in s
ched
ule
2
Mou
se1,
362,
739
543,
255
603,
774
213
9,09
7-
1,91
9,13
8
Rat
96,2
9736
5,75
322
81,
932
-51
7-
464,
727
Gui
nea
pig
809
26,0
24-
162
-10
6-
27,1
01
Ham
ster
1,10
23,
191
-74
3-
--
5,03
6
Ger
bil
1,09
22,
559
-46
-5
-3,
702
Rab
bit
7,16
614
,422
213
-12
4-
21,7
36
Cat
499
70-
250
--
-81
9
Dog
2,29
54,
683
118
86-
836
-8,
018
Fer
ret
7795
6-
--
5-
1,03
8
Pig
(gen
etic
ally
mod
ified
)37
--
--
--
37
She
ep (g
enet
ical
ly m
odifi
ed)
--
--
--
--
Prim
ate
818
716
--
-2,
674
-4,
208
Qua
il (C
otur
nix
cotu
rnix
)-
70-
--
--
70
Ani
mal
s no
t lis
ted
--
--
--
399,
314
399,
314
Tot
al1,
472,
931
961,
699
427
6,99
621
313
,364
399,
314
2,85
4,94
4
28
Tabl
e 2.
1 Sc
ient
ific
proc
edur
es b
y Sc
hedu
le 2
list
ed s
peci
es a
nd s
ourc
e of
ani
mal
s(a
nim
als
with
a h
arm
ful g
enet
ic d
efec
t)G
reat
Brit
ain
2004
Num
ber o
f pro
cedu
res
Spe
cies
of a
nim
alS
ourc
eTo
tal
Ani
mal
s ac
quire
d fro
m w
ithin
ow
n de
sign
ated
es
tabl
ishm
ent
Ani
mal
s ac
quire
d fro
m a
noth
er
desi
gnat
ed
bree
ding
or
supp
lyin
g es
tabl
ishm
ent i
n th
e U
K
Ani
mal
s ac
quire
d fro
m n
on-
desi
gnat
ed s
ourc
es
in th
e U
K
Ani
mal
s ac
quire
d fro
m s
ourc
es w
ithin
th
e E
U (o
utsi
de th
e U
K)
Ani
mal
s ac
quire
d fro
m C
ounc
il of
E
urop
e co
untri
es
who
are
sig
nato
ries
to E
TS12
3
Ani
mal
s ac
quire
d fro
m o
ther
sou
rces
Ani
mal
s no
t lis
ted
in s
ched
ule
2(1)
Mou
se17
5,96
520
,463
-53
3-
2,09
7-
199,
058
Rat
26,5
501,
672
-38
5-
233
-28
,840
Gui
nea
pig
--
--
--
--
Ham
ster
--
--
--
--
Ger
bil
--
--
--
--
Rab
bit
217
121
--
--
-33
8
Cat
--
--
--
--
Dog
7-
--
--
-7
Fer
ret
--
--
--
--
Prim
ate
--
--
--
--
Qua
il (C
otur
nix
cotu
rnix
)-
--
--
--
-
Ani
mal
s no
t lis
ted
--
--
--
39,3
2839
,328
Tot
al20
2,73
922
,256
-91
8-
2,33
039
,328
267,
571
(1)
The
"ani
mal
s no
t lis
ted
in S
ched
ule
2" h
ere
wer
e 34
7do
mes
tic fo
wl,
1,07
5 am
phib
ia a
nd 3
7,90
6 fis
h.
29
Tabl
e 2.
2 Sc
ient
ific
proc
edur
es b
y Sc
hedu
le 2
list
ed s
peci
es a
nd s
ourc
e of
ani
mal
s(g
enet
ical
ly m
odifi
ed a
nim
als)
Gre
at B
ritai
n 20
04N
umbe
r of p
roce
dure
s
Spe
cies
of a
nim
alS
ourc
eTo
tal
Ani
mal
s ac
quire
d fro
m w
ithin
ow
n de
sign
ated
es
tabl
ishm
ent
Ani
mal
s ac
quire
d fro
m a
noth
er
desi
gnat
ed
bree
ding
or
supp
lyin
g es
tabl
ishm
ent i
n th
e U
K
Ani
mal
s ac
quire
d fro
m n
on-
desi
gnat
ed s
ourc
es
in th
e U
K
Ani
mal
s ac
quire
d fro
m s
ourc
es w
ithin
th
e E
U (o
utsi
de th
e U
K)
Ani
mal
s ac
quire
d fro
m C
ounc
il of
E
urop
e co
untri
es
who
are
sig
nato
ries
to E
TS12
3
Ani
mal
s ac
quire
d fro
m o
ther
sou
rces
Ani
mal
s no
t lis
ted
in s
ched
ule
2 (1
)
Mou
se85
5,29
915
,449
-1,
991
167
4,54
5-
877,
451
Rat
2,57
828
-14
9-
3-
2,75
8
Gui
nea
pig
--
--
--
--
Ham
ster
--
--
--
--
Ger
bil
--
--
--
--
Rab
bit
--
--
--
--
Cat
--
--
--
--
Dog
--
--
--
--
Fer
ret
--
--
--
--
Pig
(gen
etic
ally
mod
ified
)37
--
--
--
37
She
ep (g
enet
ical
ly m
odifi
ed)
--
--
--
--
Prim
ate
--
--
--
--
Qua
il (C
otur
nix
cotu
rnix
)-
--
--
--
-
Ani
mal
s no
t lis
ted
--
--
--
33,7
7733
,777
Tot
al85
7,91
415
,477
-2,
140
167
4,54
833
,777
914,
023
(1)
The
"ani
mal
s no
t lis
ted
in S
ched
ule
2" h
ere
wer
e 11
4 do
mes
tic fo
wl,
1,85
9 am
phib
ia a
nd 3
1,80
4 fis
h.
30
Table 3 Scientific procedures by species of animal, primary purpose and genetic status
Great Britain 2004 Number of procedures
Species of animal Primary purpose of procedure Genetic status Total
Normal animal Animal with
harmful genetic
defect
Genetically
modified
animal
Mouse Fundamental biological research 311,956 45,263 244,108 601,327
Applied studies 309,874 40,124 25,127 375,125
Safety 24,548 30 21 24,599
Other uses 7,786 77 647 8,510
Breeding 188,465 113,564 607,548 909,577
Total 842,629 199,058 877,451 1,919,138
Rat Fundamental biological research 122,882 2,318 1,324 126,524
Applied studies 262,188 6,300 - 268,488
Safety 44,246 - 47 44,293
Other uses 1,764 - - 1,764
Breeding 2,049 20,222 1,387 23,658
Total 433,129 28,840 2,758 464,727
Guinea pig Fundamental biological research 2,751 - - 2,751
Applied studies 23,701 - - 23,701
Safety 217 - - 217
Other uses 432 - - 432
Breeding - - - -
Total 27,101 - - 27,101
Hamster Fundamental biological research 2,328 - - 2,328
Applied studies 2,708 - - 2,708
Safety - - - -
Other uses - - - -
Breeding - - - -
Total 5,036 - - 5,036
Gerbil Fundamental biological research 1,775 - - 1,775
Applied studies 1,927 - - 1,927
Safety - - - -
Other uses - - - -
Breeding - - - -
Total 3,702 - - 3,702
Other rodent Fundamental biological research 1,431 - - 1,431
Applied studies 114 - - 114
Safety 91 - - 91
Other uses - - - -
Breeding - - - -
Total 1,636 - - 1,636
Rabbit Fundamental biological research 1,867 2 - 1,869
Applied studies 15,208 119 - 15,327
Safety 2,534 - - 2,534
Other uses 1,789 - - 1,789
Breeding - 217 - 217
Total 21,398 338 - 21,736
Cat Fundamental biological research 207 - - 207
Applied studies 612 - - 612
Safety - - - -
Other uses - - - -
Breeding - - - -
Total 819 - - 819
Dog - Beagle Fundamental biological research 120 - - 120
Applied studies 7,288 - - 7,288
Safety 147 - - 147
Other uses 244 - - 244
Breeding - - - -
Total 7,799 - - 7,799
Dog - Other Fundamental biological research 21 - - 21
Applied studies 191 7 - 198
Safety - - - -
Other uses - - - -
Breeding - - - -
Total 212 7 - 219
Ferret Fundamental biological research 169 - - 169
Applied studies 830 - - 830
Safety - - - -
Other uses 39 - - 39
Breeding - - - -
Total 1,038 - - 1,038
31
Table 3 Scientific procedures by species of animal, primary purpose and genetic status (Continued)
Great Britain 2004 Number of procedures
Species of animal Primary purpose of procedure Genetic status Total
Normal
animal
Animal with
harmful genetic
defect
Genetically
modified
animal
Other carnivore Fundamental biological research 601 - - 601
Applied studies 152 - - 152
Safety 76 - - 76
Other uses - - - -
Breeding - - - -
Total 829 - - 829
Horse, Donkey etc Fundamental biological research 356 - - 356
Applied studies 280 - - 280
Safety 5 - - 5
Other uses 7,876 - - 7,876
Breeding - - - -
Total 8,517 - - 8,517
Pig Fundamental biological research 2,923 - - 2,923
Applied studies 6,284 - - 6,284
Safety 107 - - 107
Other uses 1,815 - - 1,815
Breeding 16 - 37 53
Total 11,145 - 37 11,182
Goat Fundamental biological research 322 - - 322
Applied studies 67 - - 67
Safety 4 - - 4
Other uses 2 - - 2
Breeding - - - -
Total 395 - - 395
Sheep Fundamental biological research 6,670 - - 6,670
Applied studies 13,708 - - 13,708
Safety - - - -
Other uses 20,876 - - 20,876
Breeding 29 - - 29
Total 41,283 - - 41,283
Cattle Fundamental biological research 3,439 - - 3,439
Applied studies 10,158 - - 10,158
Safety 19 - - 19
Other uses 4 - - 4
Breeding - - - -
Total 13,620 - - 13,620
Deer Fundamental biological research 132 - - 132
Applied studies 14 - - 14
Safety - - - -
Other uses - - - -
Breeding - - - -
Total 146 - - 146
Other ungulate Fundamental biological research - - - -
Applied studies - - - -
Safety 3 - - 3
Other uses - - - -
Breeding - - - -
Total 3 - - 3
Marmoset, Tamarin Fundamental biological research 239 - - 239
Applied studies 747 - - 747
Safety - - - -
Other uses 9 - - 9
Breeding - - - -
Total 995 - - 995
Squirrel, Owl or Spider monkey Fundamental biological research - - - -
Applied studies 40 - - 40
Safety - - - -
Other uses - - - -
Breeding - - - -
Total 40 - - 40
Macaque Fundamental biological research 76 - - 76
Applied studies 2,521 - - 2,521
Safety 575 - - 575
Other uses 1 - - 1
Breeding - - - -
Total 3,173 - - 3,173
32
Table 3 Scientific procedures by species of animal, primary purpose and genetic status (Continued)
Great Britain 2004 Number of procedures
Species of animal Primary purpose of procedure Genetic status Total
Normal
animal
Animal with
harmful genetic
defect
Genetically
modified
animal
Other mammal Fundamental biological research 2,272 - - 2,272
Applied studies 39 - - 39
Safety 82 - - 82
Other uses - - - -
Breeding - - - -
Total 2,393 - - 2,393
Domestic fowl Fundamental biological research 21,607 - - 21,607
Applied studies 68,576 - - 68,576
Safety 1,571 - - 1,571
Other uses 1,712 - - 1,712
Breeding 104 347 114 565
Total 93,570 347 114 94,031
Turkey Fundamental biological research 1,401 - - 1,401
Applied studies 332 - - 332
Safety - - - -
Other uses 194 - - 194
Breeding - - - -
Total 1,927 - - 1,927
Quail (Coturnix coturnix ) Fundamental biological research 70 - - 70
Applied studies - - - -
Safety - - - -
Other uses - - - -
Breeding - - - -
Total 70 - - 70
Quail (spp. other than Fundamental biological research 60 - - 60
Coturnix coturnix ) Applied studies - - - -
Safety 506 - - 506
Other uses - - - -
Breeding - - - -
Total 566 - - 566
Other bird Fundamental biological research 7,489 - - 7,489
Applied studies 371 - - 371
Safety 182 - - 182
Other uses 670 - - 670
Breeding - - - -
Total 8,712 - - 8,712
Reptile Fundamental biological research 52 - - 52
Applied studies 1,294 - - 1,294
Safety 8 - - 8
Other uses - - - -
Breeding - - - -
Total 1,354 - - 1,354
Amphibian Fundamental biological research 13,459 1,075 1,495 16,029
Applied studies - - - -
Safety 613 - - 613
Other uses 963 - - 963
Breeding 226 - 364 590
Total 15,261 1,075 1,859 18,195
Fish Fundamental biological research 53,511 20,070 5,056 78,637
Applied studies 27,164 - 260 27,424
Safety 38,449 - - 38,449
Other uses 2,101 - - 2,101
Breeding 3,627 17,836 26,488 47,951
Total 124,852 37,906 31,804 194,562
All species Fundamental biological research 560,186 68,728 251,983 880,897
Applied studies 756,388 46,550 25,387 828,325
Safety 113,983 30 68 114,081
Other uses 48,277 77 647 49,001
Breeding 194,516 152,186 635,938 982,640
TOTAL 1,673,350 267,571 914,023 2,854,944
Species not listed had no procedures
33
34
Gre
at B
ritai
n 20
04N
umbe
r of p
roce
dure
sS
peci
es o
f ani
mal
Gen
erat
ion
of fo
unde
r ge
netic
ally
mod
ified
an
imal
s
Nor
mal
ani
mal
s w
ithin
ge
netic
ally
mod
ified
br
eedi
ng c
olon
ies
Nor
mal
ani
mal
s w
ithin
ha
rmfu
l mut
ant b
reed
ing
colo
nies
Tota
ls
Mou
se88
,058
93,4
286,
979
188,
465
Rat
871
1,14
830
2,04
9
Oth
er ro
dent
--
--
Rab
bit
--
--
Cat
--
--
Dog
--
--
Fer
ret
--
--
Oth
er c
arni
vore
--
--
Hor
se a
nd o
ther
equ
ids
--
--
Pig
16-
-16
She
ep29
--
29
Oth
er u
ngul
ate
--
--
New
Wor
ld m
onke
y-
--
-
Old
Wor
ld m
onke
y-
--
-
Oth
er m
amm
al-
--
-
Bird
104
--
104
Rep
tile
/ Am
phib
ian
226
--
226
Fis
h3,
532
-95
3,62
7
Tot
al92
,836
94,5
767,
104
194,
516
Tabl
e 3.
1 Pr
oced
ures
usi
ng g
enet
ical
ly n
orm
al a
nim
als
for t
he p
rodu
ctio
n an
d br
eedi
ng o
f ge
netic
ally
mod
ified
or h
arm
ful m
utan
t ani
mal
s
35
Tabl
e 3.
2 P
roce
dure
s us
ing
harm
ful m
utan
t ani
mal
s in
bre
edin
g pr
oced
ures
or r
esea
rch
Gre
at B
ritai
n 20
04N
umbe
r of p
roce
dure
sS
peci
es o
f ani
mal
Mai
nten
ance
of
bree
ding
col
ony
Use
d fo
r fur
ther
no
n-re
gula
ted
scie
ntifi
c pu
rpos
e (1
)
Use
d in
furth
er
regu
late
d pr
oced
ures
Use
d in
pro
duct
ion
and
othe
r pr
oced
ures
(2)
Use
d in
saf
ety
eval
uatio
n st
udie
s (3
)
Tota
ls
Mou
se11
3,64
78,
709
46,1
4629
,546
1,01
019
9,05
8
Rat
20,2
2240
16,
466
1,75
1-
28,8
40
Oth
er ro
dent
--
--
--
Rab
bit
217
-11
92
-33
8
Cat
--
--
--
Dog
--
7-
-7
Fer
ret
--
--
--
Oth
er c
arni
vore
--
--
--
Hor
se a
nd o
ther
equ
ids
--
--
--
Oth
er u
ngul
ate
--
--
--
New
Wor
ld m
onke
y-
--
--
-
Old
Wor
ld m
onke
y-
--
--
-
Oth
er m
amm
al-
--
--
-
Bird
347
--
--
347
Rep
tile
/ Am
phib
ian
-56
4-
511
-1,
075
Fis
h17
,836
2,78
917
,281
--
37,9
06 T
otal
152,
269
12,4
6370
,019
31,8
101,
010
267,
571
(1)
See
Ann
ex A
of A
ppen
dix
B
(2)
Incl
udes
pro
duct
ion
of v
ario
us b
iolo
gica
l mat
eria
ls (c
odes
B50
-B56
in A
ppen
dix
B);
also
incl
udes
pro
cedu
res
not c
once
rned
with
pro
duct
ion
(cod
e B
79)
(3)
Rep
orte
d us
ing
A c
odes
in ro
ws
10-1
2 (s
ee A
ppen
dix
B)
36
Tabl
e 3.
3 Pr
oced
ures
usi
ng g
enet
ical
ly m
odifi
ed a
nim
als
in b
reed
ing
proc
edur
es o
r res
earc
h
Gre
at B
ritai
n 20
04N
umbe
r of p
roce
dure
sS
peci
es o
f ani
mal
Gen
erat
ion
of
foun
der a
nim
als
Mai
nten
ance
of
bree
ding
col
ony
Use
d fo
r fur
ther
no
n-re
gula
ted
scie
ntifi
c pu
rpos
e (1
)
Use
d in
furth
er
regu
late
d pr
oced
ures
Use
d in
pro
duct
ion
and
othe
r pr
oced
ures
(2)
Use
d in
saf
ety
eval
uatio
n st
udie
s (3
)
Tota
l
Mou
se12
,201
595,
347
108,
330
100,
950
59,0
751,
548
877,
451
Rat
301,
357
850
270
251
-2,
758
Oth
er ro
dent
--
--
--
-
Rab
bit
--
--
--
-
Cat
--
--
--
-
Dog
--
--
--
-
Fer
ret
--
--
--
-
Oth
er c
arni
vore
--
--
--
-
Hor
se a
nd o
ther
equ
ids
--
--
--
-
Pig
-37
--
--
37
She
ep-
--
--
--
Oth
er u
ngul
ate
--
--
--
-
New
Wor
ld m
onke
y-
--
--
--
Old
Wor
ld m
onke
y-
--
--
--
Oth
er m
amm
al-
--
--
--
Bird
5658
--
--
114
Rep
tile
/ Am
phib
ian
229
135
222
988
285
-1,
859
Fis
h69
025
,798
4,98
4-
332
-31
,804
Tot
al13
,206
622,
732
114,
386
102,
208
59,9
431,
548
914,
023
(1)
See
Ann
ex A
of A
ppen
dix
B
(2)
Incl
udes
pro
duct
ion
of v
ario
us b
iolo
gica
l mat
eria
ls (c
odes
B50
-B56
in A
ppen
dix
B);
also
incl
udes
pro
cedu
res
not c
once
rned
with
pro
duct
ion
(cod
e B
79)
(3)
Rep
orte
d us
ing
A c
odes
in ro
ws
10-1
2 (s
ee A
ppen
dix
B)
37
Tabl
e 4a
Sci
entif
ic p
roce
dure
s by
spe
cies
of a
nim
al a
nd ta
rget
bod
y sy
stem
Gre
at
Brita
in 2
00
4N
um
be
r o
f p
roce
du
res
Sp
ecie
s o
f a
nim
al
Bo
dy s
yste
ms
To
tal
Re
sp
ira
tory
Ca
rdio
va
scu
lar
Ne
rvo
us
Se
nse
sA
lime
nta
ryS
kin
Mu
scu
lo -
ske
leta
l
Re
pro
du
ctive
Imm
un
e a
nd
reticu
lo -
en
do
the
lial
Oth
er
syste
mM
ultip
le
syste
ms
Syste
m n
ot
rele
va
nt
Ma
mm
al
M
ou
se
37
,88
34
5,5
24
19
7,2
04
11
,36
53
1,9
00
37
,67
83
0,1
51
16
0,8
16
44
9,6
69
25
,43
43
59
,30
15
32
,21
31
,91
9,1
38
R
at
24
,98
02
5,3
70
18
2,0
62
2,3
36
12
,44
12
,08
27
,84
82
7,0
18
12
,49
82
1,5
71
82
,89
56
3,6
26
46
4,7
27
O
the
r ro
de
nt
9,2
02
1,7
58
6,5
38
44
68
26
57
52
58
83
6,8
17
25
15
,58
15
,14
03
7,4
75
R
ab
bit
20
91
,10
37
41
65
15
61
,39
03
32
3,0
40
2,9
55
89
68
,35
03
,06
62
1,7
36
C
at
--
15
04
12
17
1-
-2
2-
50
86
81
9
D
og
23
57
48
24
71
18
16
--
23
51
26
3,8
86
2,6
23
8,0
18
F
err
et
40
11
19
60
10
16
8-
--
23
81
71
02
41
,03
8
O
the
r ca
rniv
ore
-3
-4
0-
-8
--
-1
44
63
48
29
H
ors
e,
do
nke
y a
nd
cro
ss-b
red
eq
uid
s9
01
91
--
60
14
-1
21
22
5,4
35
19
52
,38
98
,51
7
O
the
r u
ng
ula
te9
25
1,7
04
78
7-
2,7
94
36
42
75
1,9
03
17
,02
41
8,9
77
6,3
23
15
,55
36
6,6
29
P
rim
ate
Ne
w W
orld
mo
nke
y-
10
01
40
7-
--
11
13
04
18
24
61
1,0
35
Old
Wo
rld
mo
nke
y-
93
21
36
1-
-1
91
24
-7
37
1,9
80
3,1
73
O
the
r m
am
ma
l-
65
43
9-
24
1,0
37
-5
-5
52
-8
22
,39
3
Bird
1,1
40
2,7
19
5,0
79
30
59
,18
56
98
1,2
50
36
14
,99
75
6,3
17
6,9
71
16
,28
41
05
,30
6
Re
ptile
, a
mp
hib
ian
-4
29
71
87
73
6-
95
11
1,7
30
-1
,33
92
,68
61
,58
31
9,5
49
Fis
h2
,95
16
84
12
,28
87
83
2,1
76
7,4
65
3,9
90
13
,52
31
4,6
17
18
56
2,8
16
73
,08
41
94
,56
2
To
tal
78
,01
68
1,1
99
40
5,3
76
15
,67
95
9,8
06
51
,39
04
5,0
63
21
8,7
30
50
9,2
48
13
1,1
04
54
0,5
85
71
8,7
48
2,8
54
,94
4
38
Tabl
e 4b
Sci
entif
ic p
roce
dure
s by
spe
cies
of a
nim
al a
nd le
vel o
f ana
esth
esia
Gre
at B
ritai
n 20
04N
umbe
r of p
roce
dure
s
Spe
cies
of a
nim
alTy
pe o
f ana
esth
esia
Tota
lN
o an
aest
hesi
aG
ener
al a
naes
thes
ia,
with
reco
very
Loca
l ana
esth
esia
Gen
eral
ana
esth
esia
at
end
of p
roce
dure
, w
ithou
t rec
over
y
Gen
eral
ana
esth
esia
th
roug
hout
, with
out
reco
very
Mou
se1,
153,
043
353,
133
299,
005
84,8
4229
,115
1,91
9,13
8
Rat
254,
884
124,
852
1,66
344
,705
38,6
2346
4,72
7
Oth
er ro
dent
19,9
328,
135
421
4,38
44,
603
37,4
75
Rab
bit
16,1
2892
288
02,
366
1,44
021
,736
Cat
597
40-
2216
081
9
Dog
5,38
388
038
660
376
68,
018
Fer
ret
360
523
-13
142
1,03
8
Oth
er c
arni
vore
224
605
--
-82
9
Hor
se a
nd o
ther
equ
ids
605
107,
886
-16
8,51
7
Oth
er u
ngul
ates
62,6
452,
448
875
194
467
66,6
29
New
Wor
ld m
onke
y88
411
9-
428
1,03
5
Old
Wor
ld m
onke
y2,
624
499
-17
333,
173
Oth
er m
amm
al1,
121
21,
270
--
2,39
3
Bird
51,9
1133
9-
52,9
7284
105,
306
Rep
tile
/ Am
phib
ian
14,9
943,
324
-27
1,20
419
,549
Fis
h12
5,42
566
,698
-1,
923
516
194,
562
Tot
al1,
710,
760
562,
529
312,
386
192,
072
77,1
972,
854,
944
Neu
rom
uscu
lar b
lock
ing
agen
ts (N
MB
A) w
ere
used
in 3
,832
pro
cedu
res
in 2
004.
All
of th
ese
proc
edur
es in
volv
ed th
e us
e of
gen
eral
ana
esth
esia
.
39
Tabl
e 5
Scie
ntifi
c pr
oced
ures
(non
-toxi
colo
gy) b
y sp
ecie
s of
ani
mal
and
fiel
d of
rese
arch
Gre
at B
rita
in 2
004
Num
ber
of pro
cedure
s
Sp
ecie
s o
f a
nim
al
Fie
ld o
f re
se
arc
h
An
ato
my
Ph
ysio
log
yB
ioch
em
istr
yP
sych
olo
gy
Pa
tho
log
yIm
mu
no
log
yM
icro
bio
log
yP
ara
sito
log
yP
ha
rma
co
log
yP
ha
rma
ce
utica
l
R&
D
Th
era
pe
utics
Clin
ica
l
me
dic
ine
Clin
ica
l
su
rge
ry
Ma
mm
al
M
ou
se
15
7,6
98
12
6,1
02
40
,42
11
6,1
15
34
,10
04
40
,43
33
4,7
38
24
,78
73
6,1
51
18
4,5
70
13
,15
53
,78
13
32
R
at
12
,81
34
3,8
68
11
,47
11
0,3
61
2,9
26
7,7
00
68
91
,36
52
4,9
29
18
5,9
01
1,6
71
3,4
29
1,9
15
G
uin
ea
pig
-8
07
4-
17
44
51
,23
62
62
,15
91
2,3
48
--
-
H
am
ste
r1
12
31
21
25
--
69
17
91
,10
22
36
5-
-5
0
G
erb
il1
66
-4
97
-7
77
32
44
-2
,58
9-
--
O
the
r ro
de
nt
-9
-6
5-
-1
14
15
--
--
-
R
ab
bit
26
79
82
46
-8
42
,06
96
45
69
15
98
50
12
32
26
4
C
at
-1
11
--
-6
3-
16
32
19
42
64
3-
D
og
Be
ag
le-
32
--
-2
51
--
-1
,51
9-
--
Gre
yh
ou
nd
--
--
--
--
--
--
-
Oth
er
inclu
din
g c
ross-b
red
do
gs
--
--
--
--
21
--
7-
F
err
et
13
99
-5
7-
22
61
67
-2
33
88
24
--
O
the
r ca
rniv
ore
--
-4
0-
5-
--
--
--
H
ors
e,
do
nke
y a
nd
cro
ss-b
red
eq
uid
s1
61
51
-4
-1
68
7,9
62
-5
21
9-
14
-
P
ig6
31
83
-4
71
37
4,6
39
33
2-
72
36
61
01
42
G
oa
t-
43
--
23
42
41
65
14
--
-4
S
he
ep
28
71
,08
43
71
31
1,0
42
63
72
0,8
70
60
11
09
72
12
11
,25
41
64
C
att
le5
98
80
--
28
8,8
63
69
01
26
-2
21
-3
0-
D
ee
r-
--
61
4-
--
--
--
-
C
am
elid
--
--
--
--
--
--
-
O
the
r u
ng
ula
te-
--
--
--
--
--
--
P
rim
ate
Pro
sim
ian
--
--
--
--
--
--
-
Ne
w W
orld
mo
nke
y-
--
--
--
m
arm
ose
t, t
am
arin
-9
2-
66
63
0-
-4
92
23
--
-
S
qu
irre
l, o
wl, s
pid
er
mo
nke
y-
--
--
--
--
40
--
-
O
the
r N
ew
Wo
rld
mo
nke
y-
--
--
--
--
--
--
40
Tabl
e 5
Scie
ntifi
c pr
oced
ures
(non
-toxi
colo
gy) b
y sp
ecie
s of
ani
mal
and
fiel
d of
rese
arch
(Con
tinue
d)
Gre
at B
rita
in 2
004
Num
ber
of pro
cedure
s
Sp
ecie
s o
f a
nim
al
Fie
ld o
f re
se
arc
h
An
ato
my
Ph
ysio
log
y
Bio
ch
em
istr
y
Psych
olo
gy
Pa
tho
log
y
Im
mu
no
log
y
Mic
rob
iolo
gy
Pa
rasito
log
y
Ph
arm
aco
log
y
Ph
arm
ace
utica
l
R&
D
Th
era
pe
utics
Clin
ica
l
me
dic
ine
Clin
ica
l
su
rge
ry
Old
Wo
rld
mo
nke
y
M
aca
qu
e3
44
49
-9
91
6-
53
28
--
-
B
ab
oo
n-
--
--
--
--
--
--
O
the
r O
ld W
orld
mo
nke
y-
--
--
--
--
--
--
Ap
e
G
ibb
on
--
--
--
--
--
--
-
G
rea
t a
pe
--
--
--
--
--
--
-
O
the
r m
am
ma
l-
29
--
--
--
39
--
--
Bird
D
om
estic f
ow
l (G
allu
s do
mes
ticus
)2
91
1,1
48
14
36
,00
21
,12
07
,79
69
,37
95
5,5
73
-2
46
--
-
T
urk
ey
--
--
69
31
82
36
88
-1
82
--
-
Q
ua
il (C
otur
nix
cotu
rnix
)7
0-
--
--
--
--
--
-
Q
ua
il (s
pp
. o
the
r th
an
Cot
urni
x co
turn
ix)
-6
0-
--
--
--
--
--
O
the
r b
ird
-6
53
-6
44
50
92
68
17
2-
--
--
Re
ptile
A
ny r
ep
tilia
n s
pe
cie
s-
52
--
--
--
--
--
-
Am
ph
ibia
n
A
ny a
mp
hib
ian
sp
ecie
s1
2,7
15
1,5
86
1,0
24
--
--
38
85
90
--
-
Fis
h
A
ny f
ish
sp
ecie
s6
9,6
05
6,2
43
-7
39
4,5
56
9,7
85
4,2
56
2,4
79
-2
,09
93
5-
-
Ce
ph
alo
po
d
O
cto
pu
s v
ulg
aris
--
--
--
--
--
--
-
To
tal
25
3,7
87
18
4,3
92
53
,80
93
4,6
83
44
,79
64
84
,30
38
1,6
87
86
,73
16
3,7
40
39
3,0
05
15
,25
21
8,6
81
2,5
71
41
Tabl
e 5
Scie
ntifi
c pr
oced
ures
(non
-toxi
colo
gy) b
y sp
ecie
s of
ani
mal
and
fiel
d of
rese
arch
(Con
tinue
d)
Gre
at B
rita
in 2
004
Num
ber
of pro
cedure
s
Sp
ecie
s o
f a
nim
al
Fie
ld o
f re
se
arc
h T
ota
l
De
ntistr
y
Ge
ne
tics
Mo
lecu
lar
bio
log
y
Ca
nce
r
rese
arc
h
Nu
tritio
n
Zo
olo
gy
Bo
tan
y
An
ima
l scie
nce
E
co
log
y
An
ima
l w
elfa
re
Oth
er
To
ba
cco
A
lco
ho
l
Ma
mm
al
M
ou
se
-1
39
,44
51
06
,07
62
64
,79
91
,43
49
56
13
,87
81
19
4,7
22
73
,57
5-
82
51
,71
7,3
57
R
at
21
1,8
74
1,9
80
8,5
53
3,6
87
-1
4-
-2
73
4,5
38
-1
08
33
0,0
86
G
uin
ea
pig
--
3-
--
--
51
--
--
17
,09
6
H
am
ste
r-
-2
30
10
24
41
66
--
4-
--
-2
,97
0
G
erb
il-
--
20
0-
--
--
--
--
3,7
02
O
the
r ro
de
nt
--
--
32
--
-1
,37
7-
--
-1
,61
2
R
ab
bit
--
40
91
--
92
82
12
56
--
5,6
36
C
at
--
--
30
8-
--
--
--
-7
93
D
og
Be
ag
le-
--
11
6-
--
--
-1
24
--
2,0
42
Gre
yh
ou
nd
--
--
--
--
--
--
--
Oth
er
inclu
din
g c
ross-b
red
do
gs
-6
6-
-1
25
--
--
--
--
21
9
F
err
et
--
--
--
--
--
--
-9
97
O
the
r ca
rniv
ore
--
--
1-
-3
77
4-
--
-8
23
H
ors
e,
do
nke
y a
nd
cro
ss-b
red
eq
uid
s-
--
-4
3-
--
-4
0-
--
8,4
69
P
ig-
-1
5-
1,7
39
--
1,7
92
-2
16
--
-9
,55
5
G
oa
t-
--
-7
7-
--
--
--
-3
54
S
he
ep
-4
69
--
82
7-
-2
,60
5-
13
1-
--
40
,69
2
C
att
le-
22
--
15
2-
-2
08
13
1,0
39
--
-1
2,3
31
D
ee
r-
78
--
--
-4
8-
--
--
14
6
C
am
elid
--
--
--
--
--
--
--
O
the
r u
ng
ula
te-
--
--
--
-3
--
--
3
P
rim
ate
Pro
sim
ian
--
--
--
--
--
--
--
Ne
w W
orld
mo
nke
y
m
arm
ose
t, t
am
arin
--
-2
6-
--
--
--
--
49
2
S
qu
irre
l, o
wl, s
pid
er
mo
nke
y-
--
--
--
--
--
--
40
O
the
r N
ew
Wo
rld
mo
nke
y-
--
--
--
--
--
--
-
42
Tabl
e 5
Scie
ntifi
c pr
oced
ures
(non
-toxi
colo
gy) b
y sp
ecie
s of
ani
mal
and
fiel
d of
rese
arch
(Con
tinue
d)
Gre
at B
rita
in 2
004
Num
ber
of pro
cedure
s
Sp
ecie
s o
f a
nim
al
Fie
ld o
f re
se
arc
h T
ota
l
De
ntistr
y
Ge
ne
tics
Mo
lecu
lar
bio
log
y
Ca
nce
r
rese
arc
h
Nu
tritio
n
Zo
olo
gy
Bo
tan
y
An
ima
l scie
nce
E
co
log
y
An
ima
l w
elfa
re
Oth
er
To
ba
cco
A
lco
ho
l
Old
Wo
rld
mo
nke
y
M
aca
qu
e-
--
--
--
--
--
--
50
8
B
ab
oo
n-
--
--
--
--
--
--
-
O
the
r O
ld W
orld
mo
nke
y-
--
--
--
--
--
--
-
Ap
e
G
ibb
on
--
--
--
--
--
--
--
G
rea
t a
pe
--
--
--
--
--
--
--
O
the
r m
am
ma
l-
48
51
,75
8-
--
--
82
--
--
2,3
93
Bird
D
om
estic f
ow
l (G
allu
s do
mes
ticus
)-
95
45
-3
,88
6-
-2
52
93
24
9-
--
87
,13
7
T
urk
ey
--
--
61
4-
--
-3
8-
--
1,8
69
Q
ua
il (C
otur
nix
cotu
rnix
)-
--
--
--
--
--
--
70
Q
ua
il (s
pp
. o
the
r th
an
Cot
urni
x co
turn
ix)
--
--
--
--
--
--
-6
0
O
the
r b
ird
-9
32
--
34
70
6-
-4
,53
6-
--
-8
,63
4
Re
ptile
A
ny r
ep
tilia
n s
pe
cie
s-
--
--
--
-8
--
--
60
Am
ph
ibia
n
A
ny a
mp
hib
ian
sp
ecie
s-
45
67
85
21
--
2-
94
3-
--
-1
8,1
95
Fis
h
A
ny f
ish
sp
ecie
s-
1,3
07
83
90
56
,09
27
,17
4-
2,0
52
27
,66
66
--
-1
45
,08
2
Ce
ph
alo
po
d
O
cto
pu
s v
ulg
aris
--
--
--
--
--
--
--
To
tal
21
14
5,6
77
11
0,8
68
27
5,2
21
19
,29
58
,14
13
12
0,8
40
35
,75
16
,71
57
8,4
93
-9
33
2,4
19
,42
3
43
Tabl
e 5a
Ani
mal
s (n
on-to
xico
logy
) by
spec
ies
of a
nim
al a
nd fi
eld
of re
sear
ch
Gre
at B
ritai
n 20
04N
umbe
r of a
nim
als
Spe
cies
of a
nim
alFi
eld
of re
sear
ch A
nato
my
Phy
siol
ogy
Bio
chem
istry
P
sych
olog
y P
atho
logy
Im
mun
olog
y M
icro
biol
ogy
Par
asito
logy
P
harm
acol
ogy
Pha
rmac
eutic
al
R&
D
The
rape
utic
s C
linic
al
med
icin
e C
linic
al
surg
ery
Mam
mal
Mou
se15
6,40
912
4,84
539
,958
16,1
1534
,000
440,
302
34,7
3824
,787
33,3
2318
3,53
613
,139
3,78
133
2 R
at12
,813
43,6
4311
,471
9,55
72,
926
7,70
068
91,
289
24,6
8317
9,67
21,
671
3,36
81,
915
Gui
nea
pig
-80
74
-17
445
1,20
826
2,15
912
,245
--
- H
amst
er11
231
212
5-
-69
179
800
236
5-
-50
Ger
bil
166
-44
9-
7773
244
-2,
589
--
- O
ther
rode
nt-
9-
65-
-11
415
--
--
- R
abbi
t26
798
67-
842,
059
586
3015
980
911
222
64 C
at-
111
--
-36
--
3219
426
43-
Dog
B
eagl
e-
32-
--
235
--
-74
3-
--
G
reyh
ound
--
--
--
--
--
--
-
Oth
er in
clud
ing
cros
s-br
ed d
ogs
--
--
--
--
21-
-7
- F
erre
t13
99-
57-
226
158
-23
384
18-
- O
ther
car
nivo
re-
--
40-
5-
--
--
--
Hor
se, d
onke
y an
d cr
oss-
bred
equ
ids
1620
-4
-9
183
--
19-
13-
Pig
6318
3-
4713
44,
365
332
-5
224
610
142
Goa
t-
12-
-23
424
165
14-
--
4 S
heep
286
1,03
637
131
1,03
154
553
260
110
8321
211
,227
164
Cat
tle59
849
--
282,
002
690
126
-21
9-
30-
Dee
r-
--
614
--
--
--
--
Cam
elid
--
--
--
--
--
--
- O
ther
ung
ulat
e-
--
--
--
--
--
--
Prim
ate
P
rosi
mia
n-
--
--
--
--
--
--
N
ew W
orld
mon
key
mar
mos
et, t
amar
in-
81-
666
29-
-49
37-
--
Squ
irrel
, ow
l, sp
ider
mon
key
--
--
--
--
--
--
-
O
ther
New
Wor
ld m
onke
y-
--
--
--
--
--
--
44
Tabl
e 5a
Ani
mal
s (n
on-to
xico
logy
) by
spec
ies
of a
nim
al a
nd fi
eld
of re
sear
ch (C
ontin
ued)
Gre
at B
ritai
n 20
04N
umbe
r of a
nim
als
Spe
cies
of a
nim
alFi
eld
of re
sear
ch A
nato
my
Phy
siol
ogy
Bio
chem
istry
P
sych
olog
y P
atho
logy
Im
mun
olog
y M
icro
biol
ogy
Par
asito
logy
P
harm
acol
ogy
Pha
rmac
eutic
al
R&
D
The
rape
utic
s C
linic
al
med
icin
e C
linic
al
surg
ery
O
ld W
orld
mon
key
Mac
aque
328
49
-68
16-
553
--
-
B
aboo
n-
--
--
--
--
--
--
Oth
er O
ld W
orld
mon
key
--
--
--
--
--
--
-
Ape
Gib
bon
--
--
--
--
--
--
-
G
reat
ape
--
--
--
--
--
--
-
Oth
er m
amm
al-
29-
--
--
-39
--
--
Bird
Dom
estic
fow
l (G
allu
s do
mes
ticus
)86
1,14
814
36,
002
760
7,79
59,
379
55,5
73-
245
--
- T
urke
y-
--
-69
318
8288
-12
7-
--
Qua
il (C
otur
nix
cotu
rnix
)70
--
--
--
--
--
--
Qua
il (s
pp,o
ther
than
Cot
urni
x co
turn
ix)
-60
--
--
--
--
--
- O
ther
bird
-57
0-
644
5088
681
72-
--
--
Rep
tile
Any
rept
ilian
spe
cies
-52
--
--
--
--
--
-A
mph
ibia
n A
ny a
mph
ibia
n sp
ecie
s6,
988
1,34
518
0-
--
-3
6059
0-
--
Fish
Any
fish
spe
cies
68,6
276,
243
-73
94,
556
9,78
54,
251
2,47
9-
2,09
935
--
Cep
halo
pod
Oct
opus
vul
garis
--
--
--
--
--
--
-
Tota
l24
5,58
718
2,31
852
,323
33,8
3144
,322
476,
660
53,3
1586
,298
60,5
8438
4,23
315
,219
18,5
922,
571
45
Tabl
e 5a
Ani
mal
s (n
on-to
xico
logy
) by
spec
ies
of a
nim
al a
nd fi
eld
of re
sear
ch (C
ontin
ued)
Gre
at B
ritai
n 20
04N
umbe
r of a
nim
als
Spe
cies
of a
nim
alFi
eld
of re
sear
ch T
otal
D
entis
try
Gen
etic
s M
olec
ular
bi
olog
y C
ance
r re
sear
ch
Nut
ritio
n Z
oolo
gy
Bot
any
Ani
mal
sci
ence
E
colo
gy
Ani
mal
wel
fare
O
ther
T
obac
co
Alc
ohol
Mam
mal
Mou
se-
139,
371
105,
460
263,
814
1,43
495
613
,878
119
4,72
273
,575
-59
01,
708,
329
Rat
211,
874
1,98
08,
553
3,68
7-
14-
-27
34,
538
-10
832
2,44
5 G
uine
a pi
g-
-3
--
--
-51
--
--
16,9
65 H
amst
er-
-23
010
244
16-
-4
--
--
2,51
8 G
erbi
l-
--
200
--
--
--
--
-3,
654
Oth
er ro
dent
--
--
32-
--
1,37
7-
--
-1,
612
Rab
bit
--
4091
--
92
821
249
--
5,29
0 C
at-
--
-50
--
--
--
--
492
Dog
B
eagl
e-
--
14-
--
--
-7
--
1,03
1
Gre
yhou
nd-
--
--
--
--
--
--
-
Oth
er in
clud
ing
cros
s-br
ed d
ogs
-66
--
--
--
--
--
-94
Fer
ret
--
--
--
--
--
--
-97
8 O
ther
car
nivo
re-
--
-1
--
376
6-
--
-81
5 H
orse
, don
key
and
cros
s-br
ed e
quid
s-
--
-43
--
--
--
--
307
Pig
--
15-
1,72
7-
-1,
792
-21
6-
--
9,25
2 G
oat
--
--
77-
--
--
--
-32
3 S
heep
-46
9-
-77
2-
-2,
546
-56
--
-19
,972
Cat
tle-
22-
-10
3-
-16
813
221
--
-4,
530
Dee
r-
78-
--
--
48-
--
--
146
Cam
elid
--
--
--
--
--
--
--
Oth
er u
ngul
ate
--
--
--
--
3-
--
-3
Prim
ate
P
rosi
mia
n-
--
--
--
--
--
--
-
New
Wor
ld m
onke
y
m
arm
oset
, tam
arin
--
-26
--
--
--
--
-29
4
S
quirr
el, o
wl,
spid
er m
onke
y-
--
--
--
--
--
--
-
O
ther
New
Wor
ld m
onke
y-
--
--
--
--
--
--
-
46
Tabl
e 5a
Ani
mal
s (n
on-to
xico
logy
) by
spec
ies
of a
nim
al a
nd fi
eld
of re
sear
ch (C
ontin
ued)
Gre
at B
ritai
n 20
04N
umbe
r of a
nim
als
Spe
cies
of a
nim
alFi
eld
of re
sear
ch T
otal
D
entis
try
Gen
etic
s M
olec
ular
bi
olog
y C
ance
r re
sear
ch
Nut
ritio
n Z
oolo
gy
Bot
any
Ani
mal
sci
ence
E
colo
gy
Ani
mal
wel
fare
O
ther
T
obac
co
Alc
ohol
O
ld W
orld
mon
key
Mac
aque
--
--
--
--
--
--
-18
6
B
aboo
n-
--
--
--
--
--
--
-
O
ther
Old
Wor
ld m
onke
y-
--
--
--
--
--
--
-
Ape
Gib
bon
--
--
--
--
--
--
--
Gre
at a
pe-
--
--
--
--
--
--
-
Oth
er m
amm
al-
485
1,75
8-
--
--
74-
--
-2,
385
Bird
Dom
estic
fow
l (G
allu
s do
mes
ticus
)-
954
5-
3,88
6-
-25
293
249
--
-86
,570
Tur
key
--
--
614
--
--
38-
--
1,66
0 Q
uail
(Cot
urni
x co
turn
ix)
--
--
--
--
--
--
-70
Qua
il (s
pp,o
ther
than
Cot
urni
x co
turn
i x)
--
--
--
--
--
--
-60
Oth
er b
ird-
932
--
869
7-
-4,
536
--
--
8,47
6R
eptil
e A
ny re
ptili
an s
peci
es-
--
--
--
-8
--
--
60A
mph
ibia
n A
ny a
mph
ibia
n sp
ecie
s-
4554
023
9-
--
-93
9-
--
-10
,929
Fish
Any
fish
spe
cies
-1,
307
8390
56,
064
7,17
4-
2,05
227
,666
6-
--
144,
071
Cep
halo
pod
Oct
opus
vul
garis
--
--
--
--
--
--
--
Tota
l21
145,
603
110,
114
273,
852
18,7
427,
982
2920
,741
35,7
315,
782
78,3
69-
698
2,35
3,51
7
47
Tabl
e 5.
1 Sc
ient
ific
proc
edur
es (n
on-to
xico
logy
) by
spec
ies
of a
nim
al a
nd fi
eld
of re
sear
ch(a
nim
als
with
a h
arm
ful g
enet
ic d
efec
t)G
reat
Brit
ain
2004
Num
ber o
f pro
cedu
res
Spe
cies
of a
nim
alFi
eld
of re
sear
chA
nato
my
Phy
siol
ogy
Bio
chem
istry
Psy
chol
ogy
Pat
holo
gyIm
mun
olog
yM
icro
biol
ogy
Par
asito
logy
Pha
rmac
olog
yP
harm
aceu
tical
R
&D
Ther
apeu
tics
Clin
ical
m
edic
ine
Clin
ical
su
rger
y
Mam
mal
Mou
se11
,424
8,64
766
910
3,57
026
,567
385
730
685
2,52
349
324
423
Rat
598
5,00
64,
947
445
113
816
-53
337
5,90
413
1,48
5-
Oth
er ro
dent
--
--
--
--
--
--
- R
abbi
t-
--
-2
--
--
119
--
- C
at-
--
--
--
--
--
--
Dog
O
ther
incl
udin
g cr
oss-
bred
dog
s-
--
--
--
--
--
7-
Oth
er m
amm
al-
--
--
--
--
--
--
Bird
Dom
estic
fow
l (G
allu
s do
mes
ticu s
)-
--
--
--
--
--
--
Am
phib
ian
Any
am
phib
ian
spec
ies
1,07
5-
--
--
--
--
--
-Fi
sh A
ny fi
sh s
peci
es37
,256
--
--
--
--
220
--
-
Tota
l50
,353
13,6
535,
616
455
3,68
527
,383
385
783
1,02
28,
766
506
1,73
623
Tabl
e 5.
1 (C
ontin
ued)
Gre
at B
ritai
n 20
04N
umbe
r of p
roce
dure
sS
peci
es o
f ani
mal
Fiel
d of
rese
arch
Tot
al
Den
tistry
G
enet
ics
Mol
ecul
ar
biol
ogy
Can
cer
rese
arch
N
utrit
ion
Zoo
logy
B
otan
y A
nim
al s
cien
ce
Eco
logy
A
nim
al w
elfa
re
Oth
er
Tob
acco
A
lcoh
ol
Mam
mal
Mou
se-
23,8
892,
930
85,1
1875
--
--
1130
,055
--
198,
048
Rat
-1,
736
-3,
056
--
--
--
4,33
1-
-28
,840
Oth
er ro
dent
--
--
--
--
--
--
--
Rab
bit
--
--
--
--
--
217
--
338
Cat
--
--
--
--
--
--
--
Dog
O
ther
incl
udin
g cr
oss-
bred
dog
s-
--
--
--
--
--
--
7O
ther
mam
mal
--
--
--
--
--
--
--
Bird
Dom
estic
fow
l (G
allu
s do
mes
ticu s
)-
347
--
--
--
--
--
-34
7A
mph
ibia
n A
ny a
mph
ibia
n sp
ecie
s-
--
--
--
--
--
--
1,07
5Fi
sh A
ny fi
sh s
peci
es-
430
--
--
--
--
--
-37
,906
Tota
l-
26,4
022,
930
88,1
7475
--
--
1134
,603
--
266,
561
48
Tabl
e 5.
2 Sc
ient
ific
proc
edur
es (n
on-to
xico
logy
) by
spec
ies
of a
nim
al a
nd fi
eld
of re
sear
ch(g
enet
ical
ly m
odifi
ed a
nim
als)
Gre
at B
ritai
n 20
04N
umbe
r of p
roce
dure
sS
peci
es o
f ani
mal
Fiel
d of
rese
arch
Ana
tom
yP
hysi
olog
yB
ioch
emis
tryP
sych
olog
yP
atho
logy
Imm
unol
ogy
Mic
robi
olog
yP
aras
itolo
gyP
harm
acol
ogy
Pha
rmac
eutic
al
R&
DTh
erap
eutic
sC
linic
al
med
icin
eC
linic
al
surg
ery
Mam
mal
Mou
se94
,323
83,5
1527
,433
8,54
819
,550
269,
534
9,15
628
122
,292
47,9
744,
409
1,15
6-
Rat
661
914
4-
208
--
--
-24
--
Oth
er ro
dent
--
--
--
--
--
--
- R
abbi
t-
--
--
--
--
--
--
Pig
37-
--
--
--
--
--
- S
heep
--
--
--
--
--
--
-B
ird D
omes
tic fo
wl (
Gal
lus
dom
estic
u s)
--
--
--
--
--
--
-A
mph
ibia
n-
--
--
--
--
--
--
Any
am
phib
ian
spec
ies
1,85
9-
--
--
--
--
--
-Fi
sh A
ny fi
sh s
peci
es30
,061
--
--
--
--
318
--
-
Tota
l12
6,94
184
,429
27,4
378,
548
19,7
5826
9,53
49,
156
281
22,2
9248
,292
4,43
31,
156
-
Tabl
e 5.
2 (C
ontin
ued)
Gre
at B
ritai
n 20
04N
umbe
r of p
roce
dure
sS
peci
es o
f ani
mal
Fiel
d of
rese
arch
Tot
al
Den
tistry
G
enet
ics
Mol
ecul
ar
biol
ogy
Can
cer
rese
arch
N
utrit
ion
Zoo
logy
B
otan
y A
nim
al s
cien
ce
Eco
logy
A
nim
al w
elfa
re
Oth
er
Tob
acco
A
lcoh
ol
Mam
mal
Mou
se-
56,2
2868
,278
107,
290
286
--
13,1
77-
3,28
839
,149
-36
875,
903
Rat
--
726
-19
0-
--
-31
--
-2,
758
Oth
er ro
dent
--
--
--
--
--
--
--
Rab
bit
--
--
--
--
--
--
--
Pig
--
--
--
--
--
--
-37
She
ep-
--
--
--
--
--
--
-B
ird D
omes
tic fo
wl (
Gal
lus
dom
estic
u s)
-11
4-
--
--
--
--
--
114
Am
phib
ian
--
--
--
--
--
--
- A
ny a
mph
ibia
n sp
ecie
s-
--
--
--
--
--
--
1,85
9Fi
sh A
ny fi
sh s
peci
es-
290
--
--
-1,
135
--
--
-31
,804
Tota
l-
56,6
3269
,004
107,
290
476
--
14,3
12-
3,31
939
,149
-36
912,
475
49
Tabl
e 8
Scie
ntifi
c pr
oced
ures
(non
-toxi
colo
gy) b
y sp
ecie
s of
ani
mal
and
pro
duct
ion
of b
iolo
gica
l mat
eria
ls
Gre
at B
ritai
n 20
04N
umbe
r of p
roce
dure
s
Spe
cies
of a
nim
alP
rodu
ctio
nO
ther
(1)
Tota
lIn
fect
ious
ag
ents
Vec
tors
Neo
plas
ms
Mon
oclo
nal
antib
odie
s (a
scite
s m
odel
)
Mon
oclo
nal
antib
odie
s (in
itial
im
mun
isat
ion)
Pol
yclo
nal
antib
odie
sO
ther
bio
logi
cal
mat
eria
ls
Mou
se28
,396
2,71
411
,932
-2,
646
13,0
7783
,282
1,57
5,31
01,
717,
357
Rat
1,66
113
074
0-
662
158
25,2
3130
1,50
433
0,08
6
Oth
er ro
dent
1,04
458
2-
-10
317
439
22,9
8825
,380
Rab
bit
2068
--
452,
887
412
2,20
45,
636
Cat
-16
--
--
-77
779
3
Dog
--
--
-3
684
1,57
42,
261
Fer
ret
--
--
-55
330
612
997
Oth
er c
arni
vore
--
--
--
-82
382
3
Hor
se a
nd o
ther
equ
ids
--
--
--
5,49
12,
978
8,46
9
Oth
er u
ngul
ate
542
2-
-63
603
32,0
3929
,832
63,0
81
New
Wor
ld m
onke
y-
--
--
-46
486
532
Old
Wor
ld m
onke
y-
--
--
113
494
508
Oth
er m
amm
al-
--
--
--
2,39
32,
393
Bird
54,9
43-
--
-56
24,
504
37,7
6197
,770
Rep
tile
/ Am
phib
ian
--
--
--
8,69
69,
559
18,2
55
Fis
h1,
155
--
--
-28
014
3,64
714
5,08
2
Tot
al87
,761
3,51
212
,672
-3,
426
17,6
6316
1,44
72,
132,
942
2,41
9,42
3
(1) I
nclu
des
bree
ding
pro
cedu
res
whi
ch a
re n
ow d
etai
led
in T
able
s 3.
1 - 3
.3
50
Tabl
e 9
Scie
ntifi
c pr
oced
ures
(non
-toxi
colo
gy) b
y sp
ecie
s of
ani
mal
and
tech
niqu
es o
f par
ticul
ar in
tere
st
Gre
at
Brita
in 2
00
4N
um
be
r o
f p
roce
du
res
Sp
ecie
s o
f a
nim
al
Te
ch
niq
ue
s o
f p
art
icu
lar
inte
rest
All
oth
er
To
tal
Inte
rfe
ren
ce
with
org
an
s o
f
sp
ecia
l se
nse
Inje
ctio
n in
to
bra
in
Inte
rfe
ren
ce
with
bra
in
Psych
olo
gic
al
str
ess
Ave
rsiv
e
tra
inin
g
Ra
dia
tio
nIn
ha
latio
nT
he
rma
l in
jury
Ph
ysic
al
tra
um
a
tech
niq
ue
s
M
ou
se
11
,20
01
1,3
21
4,9
34
3,4
61
2,7
83
10
,09
72
3,3
18
64
3,8
64
1,6
46
,31
51
,71
7,3
57
R
at
10
,46
58
01
9,1
07
3,9
62
2,3
34
82
11
0,3
75
20
12
,35
52
70
,56
73
30
,08
6
O
the
r ro
de
nt
47
72
26
46
34
97
--
6,3
43
27
13
81
7,2
09
25
,38
0
R
ab
bit
60
-3
--
-1
01
-1
75
,45
55
,63
6
C
at
11
6-
45
--
--
--
63
27
93
D
og
7-
--
--
78
--
2,1
76
2,2
61
F
err
et
66
--
--
-2
48
--
68
39
97
O
the
r ca
rniv
ore
--
--
40
--
--
78
38
23
H
ors
e a
nd
oth
er
eq
uid
s-
--
--
--
--
8,4
69
8,4
69
O
the
r u
ng
ula
te3
28
13
01
62
--
21
12
12
06
2,6
05
63
,08
1
N
ew
Wo
rld
mo
nke
y-
-6
72
1-
16
--
-4
28
53
2
O
ld W
orld
mo
nke
y1
2-
27
--
--
--
46
95
08
O
the
r m
am
ma
l-
--
--
--
--
2,3
93
2,3
93
B
ird
21
43
02
55
24
,60
9-
--
-9
2,1
56
97
,77
0
R
ep
tile
/ A
mp
hib
ian
52
--
--
--
--
18
,20
31
8,2
55
F
ish
--
-3
80
--
--
83
14
4,6
19
14
5,0
82
T
ota
l2
2,4
79
12
,08
52
4,7
78
9,0
35
9,7
66
10
,93
44
0,4
84
12
31
6,5
77
2,2
73
,16
22
,41
9,4
23
51
Tabl
e 10
Sci
entif
ic p
roce
dure
s (to
xico
logy
) by
spec
ies
of a
nim
al a
nd to
xico
logi
cal p
urpo
se
Gre
at B
ritai
n 20
04N
umbe
r of p
roce
dure
sS
peci
es o
f ani
mal
Toxi
colo
gy o
r oth
er s
afet
y/ef
ficac
y ev
alua
tion
Gen
eral
saf
ety/
effic
acy
eval
uatio
nP
ollu
tion
Agr
icul
ture
Indu
stry
Hou
seho
ldFo
od a
dditi
ves
Oth
er fo
odst
uffs
Fini
shed
co
smet
ics
Cos
met
ics
ingr
edie
nts
Mam
mal
Mou
se72
2,64
48,
089
9520
--
- R
at6
20,6
8615
,651
6547
424
0-
- G
uine
a pi
g-
108
-20
--
--
Ham
ster
--
--
--
--
Ger
bil
--
--
--
--
Oth
er ro
dent
24-
--
--
--
Rab
bit
-77
91,
589
12-
--
- C
at-
--
--
--
- D
og
Bea
gle
-13
7-
--
--
-
Gre
yhou
nd-
--
--
--
-
Oth
er in
clud
ing
cros
s-br
ed d
ogs
--
--
--
--
Fer
ret
--
--
--
--
Oth
er c
arni
vore
--
--
--
--
Hor
se, d
onke
y an
d cr
oss-
bred
equ
ids
--
--
--
--
Pig
-21
2-
--
--
- G
oat
-4
--
--
--
She
ep-
--
--
--
- C
attle
-88
--
--
--
Dee
r-
--
--
--
- C
amel
id-
--
--
--
- O
ther
ung
ulat
e-
--
--
--
- P
rimat
e
Pro
sim
ian
--
--
--
--
N
ew W
orld
mon
key
--
--
--
--
mar
mos
et, t
amar
in-
--
--
--
-
S
quirr
el, o
wl,
spid
er m
onke
y-
--
--
--
-
O
ther
New
Wor
ld m
onke
y-
--
--
--
-
52
Tabl
e 10
Sci
entif
ic p
roce
dure
s (to
xico
logy
) by
spec
ies
of a
nim
al a
nd to
xico
logi
cal p
urpo
se (
Con
tinue
d)
Gre
at B
ritai
n 20
04N
umbe
r of p
roce
dure
sS
peci
es o
f ani
mal
Toxi
colo
gy o
r oth
er s
afet
y/ef
ficac
y ev
alua
tion
Gen
eral
saf
ety/
effic
acy
eval
uatio
nP
ollu
tion
Agr
icul
ture
Indu
stry
Hou
seho
ldFo
od a
dditi
ves
Oth
er fo
odst
uffs
Fini
shed
co
smet
ics
Cos
met
ics
ingr
edie
nts
O
ld W
orld
mon
key
Mac
aque
--
--
--
--
Bab
oon
--
--
--
--
Oth
er O
ld W
orld
mon
key
--
--
--
--
A
pe
G
ibbo
n-
--
--
--
-
G
reat
Ape
--
--
--
--
Oth
er m
amm
al-
--
--
--
-B
ird D
omes
tic fo
wl (
Gal
lus
dom
estic
us)
-93
7-
--
--
- T
urke
y-
--
--
--
- Q
uail
(Cot
urni
x co
turn
ix)
--
--
--
--
Qua
il (s
pp,o
ther
than
Cot
urni
x co
turn
i x)
169
337
--
--
--
Oth
er b
ird-
78-
--
--
-R
eptil
e A
ny re
ptili
an s
peci
es-
--
--
--
-A
mph
ibia
n A
ny a
mph
ibia
n sp
ecie
s-
--
--
--
-Fi
sh A
ny fi
sh s
peci
es28
,786
2,24
28,
328
8010
442
--
Cep
halo
pod
Oct
opus
vul
garis
--
--
--
--
Tota
l29
,057
28,2
5233
,657
272
598
282
--
53
Tabl
e 10
Sci
entif
ic p
roce
dure
s (to
xico
logy
) by
spec
ies
of a
nim
al a
nd to
xico
logi
cal p
urpo
se (Con
tinue
d)
Gre
at B
ritai
n 20
04N
umbe
r of p
roce
dure
sS
peci
es o
f ani
mal
Toxi
colo
gy o
r oth
er s
afet
y/ef
ficac
y ev
alua
tion
Tota
lP
harm
aceu
tical
saf
ety/
effic
acy
eval
uatio
nO
ther
pur
pose
sS
afet
y te
stin
gE
ffica
cy
test
ing
Qua
lity
cont
rol
AD
ME
and
re
sidu
eTo
xico
logy
re
sear
chTo
bacc
o sa
fety
Med
ical
de
vice
saf
ety
Met
hod
deve
lopm
ent
Oth
er
Mam
mal
Mou
se54
,191
18,7
0181
,746
10,4
9212
,408
-83
94,
205
8,27
920
1,78
1 R
at65
,063
148
2,17
719
,528
5,22
1-
663,
102
2,21
413
4,64
1 G
uine
a pi
g2,
288
1,84
75,
551
973
-90
19-
10,0
05 H
amst
er1,
721
245
684
--
-10
-2,
066
Ger
bil
--
--
--
--
--
Oth
er ro
dent
--
--
--
--
-24
Rab
bit
9,55
383
02,
622
101
136
-29
518
3-
16,1
00 C
at6
20-
--
--
--
26 D
og
Bea
gle
4,34
64
-1,
168
59-
-38
55,
757
G
reyh
ound
--
--
--
--
--
O
ther
incl
udin
g cr
oss-
bred
dog
s-
--
--
--
--
- F
erre
t8
--
15-
--
18-
41 O
ther
car
nivo
re6
--
--
--
--
6 H
orse
, don
key
and
cros
s-br
ed e
quid
s7
36-
5-
--
--
48 P
ig58
557
6-
201
18-
-25
101,
627
Goa
t-
--
--
-37
--
41 S
heep
200
184
2013
3-
-54
--
591
Cat
tle40
967
350
69-
--
--
1,28
9 D
eer
--
--
--
--
--
Cam
elid
--
--
--
--
--
Oth
er u
ngul
ate
--
--
--
--
--
Prim
ate
P
rosi
mia
n-
--
--
--
--
-
New
Wor
ld m
onke
y
m
arm
oset
, tam
arin
424
12-
67-
--
--
503
Squ
irrel
, ow
l, sp
ider
mon
key
--
--
--
--
--
Oth
er N
ew W
orld
mon
key
--
--
--
--
--
54
Tabl
e 10
Sci
entif
ic p
roce
dure
s (to
xico
logy
) by
spec
ies
of a
nim
al a
nd to
xico
logi
cal p
urpo
se (
Con
tinue
d)
Gre
at B
ritai
n 20
04N
umbe
r of p
roce
dure
sS
peci
es o
f ani
mal
Toxi
colo
gy o
r oth
er s
afet
y/ef
ficac
y ev
alua
tion
Tota
lP
harm
aceu
tical
saf
ety/
effic
acy
eval
uatio
nO
ther
pur
pose
sS
afet
y te
stin
gE
ffica
cy
test
ing
Qua
lity
cont
rol
AD
ME
and
re
sidu
eTo
xico
logy
re
sear
chTo
bacc
o sa
fety
Med
ical
de
vice
saf
ety
Met
hod
deve
lopm
ent
Oth
er
O
ld W
orld
mon
key
Mac
aque
1,77
5-
-28
8-
--
590
122,
665
Bab
oon
--
--
--
--
--
Oth
er O
ld W
orld
mon
key
--
--
--
--
--
A
pe
G
ibbo
n-
--
--
--
--
-
G
reat
Ape
--
--
--
--
--
Oth
er m
amm
al-
--
--
--
--
-B
ird D
omes
tic fo
wl (
Gal
lus
dom
estic
us)
973
4,62
692
266
--
--
-6,
894
Tur
key
--
-58
--
--
-58
Qua
il (C
otur
nix
cotu
rnix
)-
--
--
--
--
- Q
uail
(spp
,oth
er th
an C
otur
nix
cotu
rnix
)-
--
--
--
--
506
Oth
er b
ird-
--
--
--
--
78R
eptil
e A
ny re
ptili
an s
peci
es-
--
-1,
294
--
--
1,29
4A
mph
ibia
n A
ny a
mph
ibia
n sp
ecie
s-
--
--
--
--
-Fi
sh A
ny fi
sh s
peci
es3,
502
5,94
7-
449
--
--
-49
,480
Cep
halo
pod
Oct
opus
vul
garis
--
--
--
--
--
Tota
l14
5,05
733
,849
92,2
6432
,933
19,2
09-
1,38
18,
190
10,5
2043
5,52
1
55
Tabl
e 10
a A
nim
als
(toxi
colo
gy) b
y sp
ecie
s of
ani
mal
and
toxi
colo
gica
l pur
pose
Gre
at B
ritai
n 20
04N
umbe
r of a
nim
als
Spe
cies
of a
nim
alTo
xico
logy
or o
ther
saf
ety/
effic
acy
eval
uatio
nG
ener
al s
afet
y/ef
ficac
y ev
alua
tion
Pol
lutio
nA
gric
ultu
reIn
dust
ryH
ouse
hold
Food
add
itive
sO
ther
food
stuf
fsFi
nish
ed
cosm
etic
sC
osm
etic
s in
gred
ient
s
Mam
mal
Mou
se72
2,64
48,
089
9520
--
- R
at6
20,6
8615
,651
6547
424
0-
- G
uine
a pi
g-
108
-20
--
--
Ham
ster
--
--
--
--
Ger
bil
--
--
--
--
Oth
er ro
dent
24-
--
--
--
Rab
bit
-77
11,
577
12-
--
- C
at-
--
--
--
- D
og
Bea
gle
-13
7-
--
--
-
Gre
yhou
nd-
--
--
--
-
Oth
er in
clud
ing
cros
s-br
ed d
ogs
--
--
--
--
Fer
ret
--
--
--
--
Oth
er c
arni
vore
--
--
--
--
Hor
se, d
onke
y an
d cr
oss-
bred
equ
ids
--
--
--
--
Pig
-21
2-
--
--
- G
oat
-3
--
--
--
She
ep-
--
--
--
- C
attle
-88
--
--
--
Dee
r-
--
--
--
- C
amel
id-
--
--
--
- O
ther
ung
ulat
e-
--
--
--
- P
rimat
e
Pro
sim
ian
--
--
--
--
N
ew W
orld
mon
key
mar
mos
et, t
amar
in-
--
--
--
-
S
quirr
el, o
wl,
spid
er m
onke
y-
--
--
--
-
O
ther
New
Wor
ld m
onke
y-
--
--
--
-
56
Tabl
e 10
a A
nim
als
(toxi
colo
gy) b
y sp
ecie
s of
ani
mal
and
toxi
colo
gica
l pur
pose
(Con
tinue
d)
Gre
at B
ritai
n 20
04N
umbe
r of a
nim
als
Spe
cies
of a
nim
alTo
xico
logy
or o
ther
saf
ety/
effic
acy
eval
uatio
nG
ener
al s
afet
y/ef
ficac
y ev
alua
tion
Pol
lutio
nA
gric
ultu
reIn
dust
ryH
ouse
hold
Food
add
itive
sO
ther
food
stuf
fsFi
nish
ed
cosm
etic
sC
osm
etic
s in
gred
ient
s
Old
Wor
ld m
onke
y
M
acaq
ue-
--
--
--
-
B
aboo
n-
--
--
--
-
O
ther
Old
Wor
ld m
onke
y-
--
--
--
- A
pe
G
ibbo
n-
--
--
--
-
G
reat
Ape
--
--
--
--
Oth
er m
amm
al-
--
--
--
-B
ird D
omes
tic fo
wl (
Gal
lus
dom
estic
us)
-93
7-
--
--
- T
urke
y-
--
--
--
- Q
uail
(Cot
urni
x co
turn
ix)
--
--
--
--
Qua
il (s
pp,o
ther
than
Cot
urni
x co
turn
ix)
169
337
--
--
--
Oth
er b
ird-
78-
--
--
-R
eptil
e A
ny re
ptili
an s
peci
es-
--
--
--
-A
mph
ibia
n A
ny a
mph
ibia
n sp
ecie
s-
--
--
--
-Fi
sh A
ny fi
sh s
peci
es28
,786
2,24
28,
328
8010
442
--
Cep
halo
pod
Oct
opus
vul
garis
--
--
--
--
Tota
l29
,057
28,2
4333
,645
272
598
282
--
57
Tabl
e 10
a A
nim
als
(toxi
colo
gy) b
y sp
ecie
s of
ani
mal
and
toxi
colo
gica
l pur
pose
(Con
tinue
d)
Gre
at B
ritai
n 20
04N
umbe
r of a
nim
als
Spe
cies
of a
nim
alTo
xico
logy
or o
ther
saf
ety/
effic
acy
eval
uatio
nTo
tal
Pha
rmac
eutic
al s
afet
y/ef
ficac
y ev
alua
tion
Oth
er p
urpo
ses
Saf
ety
test
ing
Effi
cacy
te
stin
gQ
ualit
y co
ntro
lA
DM
E a
nd
resi
due
Toxi
colo
gy
rese
arch
Toba
cco
safe
tyM
edic
al
devi
ce s
afet
yM
etho
d de
velo
pmen
tO
ther
Mam
mal
Mou
se54
,191
18,7
0181
,746
10,4
9212
,408
-83
94,
205
8,27
920
1,78
1 R
at65
,005
148
2,17
719
,512
5,22
1-
663,
080
2,20
513
4,53
6 G
uine
a pi
g2,
280
1,84
75,
551
973
-90
19-
9,99
7 H
amst
er1,
721
245
684
--
-10
-2,
066
Ger
bil
--
--
--
--
--
Oth
er ro
dent
--
--
--
--
-24
Rab
bit
5,04
083
056
810
113
6-
204
183
-9,
422
Cat
6-
--
--
--
-6
Dog
B
eagl
e3,
944
--
316
38-
-9
14,
445
G
reyh
ound
--
--
--
--
--
O
ther
incl
udin
g cr
oss-
bred
dog
s-
--
--
--
--
- F
erre
t8
--
15-
--
18-
41 O
ther
car
nivo
re-
--
--
--
--
- H
orse
, don
key
and
cros
s-br
ed e
quid
s7
20-
5-
--
--
32 P
ig56
557
6-
197
18-
-12
101,
590
Goa
t-
--
--
-37
--
40 S
heep
200
184
2013
3-
-54
--
591
Cat
tle38
766
050
69-
--
--
1,25
4 D
eer
--
--
--
--
--
Cam
elid
--
--
--
--
--
Oth
er u
ngul
ate
--
--
--
--
--
Prim
ate
P
rosi
mia
n-
--
--
--
--
-
New
Wor
ld m
onke
y
m
arm
oset
, tam
arin
390
11-
52-
--
--
453
Squ
irrel
, ow
l, sp
ider
mon
key
--
--
--
--
--
Oth
er N
ew W
orld
mon
key
--
--
--
--
--
58
Tabl
e 10
a A
nim
als
(toxi
colo
gy) b
y sp
ecie
s of
ani
mal
and
toxi
colo
gica
l pur
pose
(Con
tinue
d)
Gre
at B
ritai
n 20
04N
umbe
r of a
nim
als
Spe
cies
of a
nim
alTo
xico
logy
or o
ther
saf
ety/
effic
acy
eval
uatio
nTo
tal
Pha
rmac
eutic
al s
afet
y/ef
ficac
y ev
alua
tion
Oth
er p
urpo
ses
Saf
ety
test
ing
Effi
cacy
te
stin
gQ
ualit
y co
ntro
lA
DM
E a
nd
resi
due
Toxi
colo
gy
rese
arch
Toba
cco
safe
tyM
edic
al
devi
ce s
afet
yM
etho
d de
velo
pmen
tO
ther
Old
Wor
ld m
onke
y
M
acaq
ue1,
387
--
55-
--
406
111,
859
Bab
oon
--
--
--
--
--
Oth
er O
ld W
orld
mon
key
--
--
--
--
--
Ape
Gib
bon
--
--
--
--
--
Gre
at A
pe-
--
--
--
--
-O
ther
mam
mal
--
--
--
--
--
Bird
Dom
estic
fow
l (G
allu
s do
mes
ticus
)97
34,
626
9226
6-
--
--
6,89
4 T
urke
y-
--
58-
--
--
58 Q
uail
(Cot
urni
x co
turn
i x)
--
--
--
--
--
Qua
il (s
pp,o
ther
than
Cot
urni
x co
turn
ix)
--
--
--
--
-50
6 O
ther
bird
--
--
--
--
-78
Rep
tile
Any
rept
ilian
spe
cies
--
--
22-
--
-22
Am
phib
ian
Any
am
phib
ian
spec
ies
--
--
--
--
--
Fish
Any
fish
spe
cies
3,50
25,
947
-44
9-
--
--
49,4
80C
epha
lopo
d O
ctop
us v
ulga
ris-
--
--
--
--
-
Tota
l13
9,60
633
,795
90,2
1031
,813
17,9
16-
1,29
07,
942
10,5
0642
5,17
5
59
Tabl
e 11
Sci
entif
ic p
roce
dure
s (to
xico
logy
) by
spec
ies
of a
nim
al, t
ype
of le
gisl
atio
n an
d
tox
icol
ogic
al p
urpo
se
Gre
at B
ritai
n 20
04N
umbe
r of p
roce
dure
sS
peci
esLe
gisl
ativ
e re
quire
men
tsTo
xico
logi
cal p
urpo
seTo
tal
Saf
ety
test
ing
othe
r th
an c
osm
etic
sP
harm
aceu
tical
sa
fety
Oth
er s
afet
y /
Toxi
colo
gy
Mou
seU
K re
quire
men
ts o
nly
242
931
2,37
33,
546
One
EU
cou
ntry
onl
y (n
ot U
K)
91-
-91
EU
requ
irem
ents
, inc
l. E
urop
ean
Pha
rmac
opoe
ia1,
148
10,6
304,
710
16,4
88R
equi
rem
ents
of (
non-
EU
) Cou
ncil
of E
urop
e -
-35
735
7R
equi
rem
ents
of o
ther
cou
ntrie
s1,
055
618
628
2,30
1A
ny c
ombi
natio
n of
abo
ve7,
930
141,
857
4,03
015
3,81
7N
on-le
gisl
ativ
e pu
rpos
es45
411
,094
13,6
3325
,181
Tota
l10
,920
165,
130
25,7
3120
1,78
1 R
atU
K re
quire
men
ts o
nly
511,
155
841,
290
One
EU
cou
ntry
onl
y (n
ot U
K)
73-
-73
EU
requ
irem
ents
, inc
l. E
urop
ean
Pha
rmac
opoe
ia5,
392
1,35
4-
6,74
6R
equi
rem
ents
of (
non-
EU
) Cou
ncil
of E
urop
e -
-25
525
5R
equi
rem
ents
of o
ther
cou
ntrie
s5,
106
1,16
553
66,
807
Any
com
bina
tion
of a
bove
24,7
6469
,529
2,95
697
,249
Non
-legi
slat
ive
purp
oses
1,73
613
,713
6,77
222
,221
Tota
l37
,122
86,9
1610
,603
134,
641
Oth
er ro
dent
UK
requ
irem
ents
onl
y-
4,82
145
4,86
6O
ne E
U c
ount
ry o
nly
(not
UK
)-
-15
15E
U re
quire
men
ts, i
ncl.
Eur
opea
n P
harm
acop
oeia
-1,
925
301,
955
Req
uire
men
ts o
f (no
n-E
U) C
ounc
il of
Eur
ope
--
--
Req
uire
men
ts o
f oth
er c
ount
ries
2046
6-
486
Any
com
bina
tion
of a
bove
-4,
430
194,
449
Non
-legi
slat
ive
purp
oses
132
109
8332
4To
tal
152
11,7
5119
212
,095
Rab
bit
UK
requ
irem
ents
onl
y6
1,21
793
1,31
6O
ne E
U c
ount
ry o
nly
(not
UK
)15
--
15E
U re
quire
men
ts, i
ncl.
Eur
opea
n P
harm
acop
oeia
348
6,13
55
6,48
8R
equi
rem
ents
of (
non-
EU
) Cou
ncil
of E
urop
e 3
--
3R
equi
rem
ents
of o
ther
cou
ntrie
s46
012
1048
2A
ny c
ombi
natio
n of
abo
ve1,
494
5,73
027
57,
499
Non
-legi
slat
ive
purp
oses
5412
231
297
Tota
l2,
380
13,1
0661
416
,100
Cat
UK
requ
irem
ents
onl
y-
--
-O
ne E
U c
ount
ry o
nly
(not
UK
)-
--
-E
U re
quire
men
ts, i
ncl.
Eur
opea
n P
harm
acop
oeia
--
--
Req
uire
men
ts o
f (no
n-E
U) C
ounc
il of
Eur
ope
--
--
Req
uire
men
ts o
f oth
er c
ount
ries
--
--
Any
com
bina
tion
of a
bove
-20
-20
Non
-legi
slat
ive
purp
oses
-6
-6
Tota
l-
26-
26
60
Tabl
e 11
Sci
entif
ic p
roce
dure
s (to
xico
logy
) by
spec
ies
of a
nim
al, t
ype
of le
gisl
atio
n an
d to
xico
logi
cal
pur
pose
(Con
tinue
d)G
reat
Brit
ain
2004
Num
ber o
f pro
cedu
res
Spe
cies
Legi
slat
ive
requ
irem
ents
Toxi
colo
gica
l pur
pose
Tota
lS
afet
y te
stin
g ot
her
than
cos
met
ics
Pha
rmac
eutic
al
safe
tyO
ther
saf
ety
/ To
xico
logy
Dog
UK
requ
irem
ents
onl
y-
--
-O
ne E
U c
ount
ry o
nly
(not
UK
)-
--
-E
U re
quire
men
ts, i
ncl.
Eur
opea
n P
harm
acop
oeia
--
--
Req
uire
men
ts o
f (no
n-E
U) C
ounc
il of
Eur
ope
--
--
Req
uire
men
ts o
f oth
er c
ount
ries
164
-20
Any
com
bina
tion
of a
bove
109
4,87
417
5,00
0N
on-le
gisl
ativ
e pu
rpos
es12
640
8573
7To
tal
137
5,51
810
25,
757
Fer
ret
UK
requ
irem
ents
onl
y-
--
-O
ne E
U c
ount
ry o
nly
(not
UK
)-
--
-E
U re
quire
men
ts, i
ncl.
Eur
opea
n P
harm
acop
oeia
--
--
Req
uire
men
ts o
f (no
n-E
U) C
ounc
il of
Eur
ope
--
--
Req
uire
men
ts o
f oth
er c
ount
ries
--
--
Any
com
bina
tion
of a
bove
-8
-8
Non
-legi
slat
ive
purp
oses
-15
1833
Tota
l-
2318
41 O
ther
car
nivo
reU
K re
quire
men
ts o
nly
-6
-6
One
EU
cou
ntry
onl
y (n
ot U
K)
--
--
EU
requ
irem
ents
, inc
l. E
urop
ean
Pha
rmac
opoe
ia-
--
-R
equi
rem
ents
of (
non-
EU
) Cou
ncil
of E
urop
e -
--
-R
equi
rem
ents
of o
ther
cou
ntrie
s-
--
-A
ny c
ombi
natio
n of
abo
ve-
--
-N
on-le
gisl
ativ
e pu
rpos
es-
--
-To
tal
-6
-6
Hor
se a
nd o
ther
equ
ids
UK
requ
irem
ents
onl
y-
7-
7O
ne E
U c
ount
ry o
nly
(not
UK
)-
--
-E
U re
quire
men
ts, i
ncl.
Eur
opea
n P
harm
acop
oeia
-21
-21
Req
uire
men
ts o
f (no
n-E
U) C
ounc
il of
Eur
ope
--
--
Req
uire
men
ts o
f oth
er c
ount
ries
--
--
Any
com
bina
tion
of a
bove
-20
-20
Non
-legi
slat
ive
purp
oses
--
--
Tota
l-
48-
48 O
ther
ung
ulat
eU
K re
quire
men
ts o
nly
-10
0-
100
One
EU
cou
ntry
onl
y (n
ot U
K)
--
--
EU
requ
irem
ents
, inc
l. E
urop
ean
Pha
rmac
opoe
ia42
1,59
1-
1,63
3R
equi
rem
ents
of (
non-
EU
) Cou
ncil
of E
urop
e -
--
-R
equi
rem
ents
of o
ther
cou
ntrie
s6
2666
98A
ny c
ombi
natio
n of
abo
ve25
61,
282
191,
557
Non
-legi
slat
ive
purp
oses
-10
159
160
Tota
l30
43,
100
144
3,54
8
61
Tabl
e 11
Sci
entif
ic p
roce
dure
s (to
xico
logy
) by
spec
ies
of a
nim
al, t
ype
of le
gisl
atio
n an
d to
xico
logi
cal
pur
pose
(Con
tinue
d)G
reat
Brit
ain
2004
Num
ber o
f pro
cedu
res
Spe
cies
Legi
slat
ive
requ
irem
ents
Toxi
colo
gica
l pur
pose
Tota
lS
afet
y te
stin
g ot
her
than
cos
met
ics
Pha
rmac
eutic
al
safe
tyO
ther
saf
ety
/ To
xico
logy
New
Wor
ld m
onke
yU
K re
quire
men
ts o
nly
--
--
One
EU
cou
ntry
onl
y (n
ot U
K)
--
--
EU
requ
irem
ents
, inc
l. E
urop
ean
Pha
rmac
opoe
ia-
--
-R
equi
rem
ents
of (
non-
EU
) Cou
ncil
of E
urop
e -
--
-R
equi
rem
ents
of o
ther
cou
ntrie
s-
--
-A
ny c
ombi
natio
n of
abo
ve-
485
-48
5N
on-le
gisl
ativ
e pu
rpos
es-
18-
18To
tal
-50
3-
503
Old
Wor
ld m
onke
yU
K re
quire
men
ts o
nly
--
--
One
EU
cou
ntry
onl
y (n
ot U
K)
--
--
EU
requ
irem
ents
, inc
l. E
urop
ean
Pha
rmac
opoe
ia-
--
-R
equi
rem
ents
of (
non-
EU
) Cou
ncil
of E
urop
e -
--
-R
equi
rem
ents
of o
ther
cou
ntrie
s-
--
-A
ny c
ombi
natio
n of
abo
ve-
2,01
859
32,
611
Non
-legi
slat
ive
purp
oses
-45
954
Tota
l-
2,06
360
22,
665
Oth
er m
amm
alU
K re
quire
men
ts o
nly
--
--
One
EU
cou
ntry
onl
y (n
ot U
K)
--
--
EU
requ
irem
ents
, inc
l. E
urop
ean
Pha
rmac
opoe
ia-
--
-R
equi
rem
ents
of (
non-
EU
) Cou
ncil
of E
urop
e -
--
-R
equi
rem
ents
of o
ther
cou
ntrie
s-
--
-A
ny c
ombi
natio
n of
abo
ve-
--
-N
on-le
gisl
ativ
e pu
rpos
es-
--
-To
tal
--
--
Bird
UK
requ
irem
ents
onl
y-
166
-16
6O
ne E
U c
ount
ry o
nly
(not
UK
)-
--
-E
U re
quire
men
ts, i
ncl.
Eur
opea
n P
harm
acop
oeia
3075
5-
785
Req
uire
men
ts o
f (no
n-E
U) C
ounc
il of
Eur
ope
--
--
Req
uire
men
ts o
f oth
er c
ount
ries
71-
-71
Any
com
bina
tion
of a
bove
1,25
15,
094
-6,
345
Non
-legi
slat
ive
purp
oses
169
--
169
Tota
l1,
521
6,01
5-
7,53
6 R
eptil
e / A
mph
ibia
nU
K re
quire
men
ts o
nly
--
1,29
41,
294
One
EU
cou
ntry
onl
y (n
ot U
K)
--
--
EU
requ
irem
ents
, inc
l. E
urop
ean
Pha
rmac
opoe
ia-
--
-R
equi
rem
ents
of (
non-
EU
) Cou
ncil
of E
urop
e -
--
-R
equi
rem
ents
of o
ther
cou
ntrie
s-
--
-A
ny c
ombi
natio
n of
abo
ve-
--
-N
on-le
gisl
ativ
e pu
rpos
es-
--
-To
tal
--
1,29
41,
294
62
Tabl
e 11
Sci
entif
ic p
roce
dure
s (to
xico
logy
) by
spec
ies
of a
nim
al, t
ype
of le
gisl
atio
n an
d to
xico
logi
cal
pur
pose
(Con
tinue
d)G
reat
Brit
ain
2004
Num
ber o
f pro
cedu
res
Spe
cies
Legi
slat
ive
requ
irem
ents
Toxi
colo
gica
l pur
pose
Tota
lS
afet
y te
stin
g ot
her
than
cos
met
ics
Pha
rmac
eutic
al
safe
tyO
ther
saf
ety
/ To
xico
logy
Fis
hU
K re
quire
men
ts o
nly
5,44
1-
-5,
441
One
EU
cou
ntry
onl
y (n
ot U
K)
67-
-67
EU
requ
irem
ents
, inc
l. E
urop
ean
Pha
rmac
opoe
ia5,
426
3,86
9-
9,29
5R
equi
rem
ents
of (
non-
EU
) Cou
ncil
of E
urop
e -
--
-R
equi
rem
ents
of o
ther
cou
ntrie
s3,
755
--
3,75
5A
ny c
ombi
natio
n of
abo
ve15
,337
5,66
1-
20,9
98N
on-le
gisl
ativ
e pu
rpos
es9,
556
368
-9,
924
Tota
l39
,582
9,89
8-
49,4
80 C
epha
lopo
dU
K re
quire
men
ts o
nly
--
--
One
EU
cou
ntry
onl
y (n
ot U
K)
--
--
EU
requ
irem
ents
, inc
l. E
urop
ean
Pha
rmac
opoe
ia-
--
-R
equi
rem
ents
of (
non-
EU
) Cou
ncil
of E
urop
e -
--
-R
equi
rem
ents
of o
ther
cou
ntrie
s-
--
-A
ny c
ombi
natio
n of
abo
ve-
--
-N
on-le
gisl
ativ
e pu
rpos
es-
--
-To
tal
--
--
All
spec
ies
UK
requ
irem
ents
onl
y5,
740
8,40
33,
889
18,0
32O
ne E
U c
ount
ry o
nly
(not
UK
)24
6-
1526
1E
U re
quire
men
ts, i
ncl.
Eur
opea
n P
harm
acop
oeia
12,3
8626
,280
4,74
543
,411
Req
uire
men
ts o
f (no
n-E
U) C
ounc
il of
Eur
ope
3-
612
615
Req
uire
men
ts o
f oth
er c
ount
ries
10,4
892,
291
1,24
014
,020
Any
com
bina
tion
of a
bove
51,1
4124
1,00
87,
909
300,
058
Non
-legi
slat
ive
purp
oses
12,1
1326
,121
20,8
9059
,124
TO
TAL
92,1
1830
4,10
339
,300
435,
521
63
Tabl
e 12
Sci
entif
ic p
roce
dure
s (to
xico
logy
) by
spec
ies
of a
nim
al a
nd ty
pe o
f tox
icol
ogic
al te
st: a
ll pu
rpos
esG
reat
Brit
ain
2004
Num
ber o
f pro
cedu
res
Spe
cies
of a
nim
alTy
pe o
f tox
icol
ogic
al te
st o
r pro
cedu
re
Acu
te le
thal
toxi
city
Acu
te le
thal
conc
entra
tion
Acu
te li
mit
setti
ngA
cute
non
- le
thal
cl
inic
al s
ign
Sub
acut
e lim
it-se
tting
or d
ose
rang
ing
Sub
acut
e to
xici
tyS
ubch
roni
c an
d ch
roni
cC
arci
noge
nici
tyG
enet
ic to
xico
logy
(in
clud
es
mut
agen
icity
)
Tera
toge
nici
ty
Mou
se83
,811
1,40
04,
285
5,41
74,
519
5,38
85,
839
8,06
84,
353
971
Rat
272,
064
2,26
79,
077
9,52
112
,845
12,8
656,
641
6,31
92,
638
Oth
er ro
dent
175
-63
020
616
419
8-
--
-
Rab
bit
--
-21
927
228
254
--
2,97
6
Cat
--
-6
--
--
--
Dog
--
-17
149
81,
598
1,59
8-
--
Fer
ret
--
--
--
--
--
Oth
er c
arni
vore
--
--
--
--
--
Hor
se a
nd o
ther
equ
ids
--
--
--
--
--
Oth
er u
ngul
ate
--
-2
836
34-
--
New
Wor
ld m
onke
y-
-6
5018
150
64-
--
Old
Wor
ld m
onke
y-
--
4018
568
057
6-
--
Oth
er m
amm
al-
--
--
--
--
-
Bird
100
6022
562
-54
2-
--
-
Rep
tile
/ Am
phib
ian
--
--
--
--
--
Fis
h-
16,5
9311
,325
-4,
820
1,91
918
4-
66-
Cep
halo
pod
--
--
--
--
--
Tot
al84
,113
20,1
1718
,738
15,2
5020
,005
23,3
8421
,414
14,7
0910
,738
6,58
5
64
Tabl
e 12
Sci
entif
ic p
roce
dure
s (to
xico
logy
) by
spec
ies
of a
nim
al a
nd ty
pe o
f tox
icol
ogic
al te
st: a
ll pu
rpos
es (C
ontin
ued)
Gre
at B
ritai
n 20
04N
umbe
r of p
roce
dure
s
Spe
cies
of a
nim
alTy
pe o
f tox
icol
ogic
al te
st o
r pro
cedu
reTo
tal
Oth
er re
prod
uctiv
e to
xici
tyIn
eye
sFo
r ski
n Irr
itatio
nFo
r ski
n se
nsiti
satio
nTo
xico
kine
tics
Pyr
ogen
icity
Bio
com
patib
ility
Enz
yme
indu
ctio
n fo
r in
vitro
test
sIm
mun
otox
icol
ogy
Oth
er to
xico
logy
Mou
se1,
445
-12
2,52
616
,383
-40
012
5,07
451
,878
201,
781
Rat
23,1
26-
6-
15,0
27-
2629
423
431
,664
134,
641
Oth
er ro
dent
--
-19
013
2-
--
2510
,375
12,0
95
Rab
bit
4280
31,
319
-20
48,
488
148
-1
1,34
616
,100
Cat
--
--
--
--
-20
26
Dog
--
--
840
--
--
1,05
25,
757
Fer
ret
--
--
--
--
-41
41
Oth
er c
arni
vore
--
--
--
--
-6
6
Hor
se a
nd o
ther
Equ
ids
--
--
--
--
-48
48
Oth
er u
ngul
ate
--
-8
240
-35
-38
42,
801
3,54
8
New
Wor
ld M
onke
y-
--
-15
9-
--
-56
503
Old
Wor
ld M
onke
y-
--
-20
7-
--
-97
72,
665
Oth
er m
amm
al-
--
--
--
--
--
Bird
--
--
217
--
--
6,33
07,
536
Rep
tile
/ Am
phib
ian
--
--
--
--
-1,
294
1,29
4
Fis
h2,
755
--
-1,
825
--
319
-9,
674
49,4
80
Cep
halo
pod
--
--
--
--
--
-
Tot
al27
,368
803
1,33
72,
724
35,2
348,
488
609
625
5,71
811
7,56
243
5,52
1
65
Tabl
e 13
: Sci
entif
ic p
roce
dure
s (to
xico
logy
) by
spec
ies
of a
nim
al a
nd ty
pe o
f tox
icol
ogic
al te
st: s
afet
y te
stin
g of
sub
stan
ces
othe
r tha
n ph
arm
aceu
tical
s
Gre
at B
ritai
n 20
04N
umbe
r of p
roce
dure
s
Spe
cies
of a
nim
alTy
pe o
f tox
icol
ogic
al te
st o
r pro
cedu
re
Acu
te le
thal
toxi
city
Acu
te le
thal
conc
entra
tion
Acu
te li
mit
setti
ngA
cute
non
- le
thal
cl
inic
al s
ign
Sub
acut
e lim
it-se
tting
or d
ose
rang
ing
Sub
acut
e to
xici
tyS
ubch
roni
c an
d ch
roni
cC
arci
noge
nici
tyG
enet
ic to
xico
logy
(in
clud
es
mut
agen
icity
)
Tera
toge
nici
ty
Mou
se-
-4
468
98-
-92
82,
650
-
Rat
271,
147
2,15
55,
164
2,60
03,
034
2,64
050
081
424
8
Oth
er ro
dent
--
-10
8-
--
--
-
Rab
bit
--
-10
50-
--
-38
4
Dog
--
-2
38-
96-
--
Hor
se a
nd o
ther
equ
ids
--
--
--
--
--
Oth
er u
ngul
ate
--
--
--
--
--
Bird
100
6022
562
-30
--
--
Rep
tile
/ Am
phib
ian
--
--
--
--
--
Fis
h-
16,5
0911
,275
-14
81,
919
184
-66
-
Tot
al12
717
,716
13,6
595,
814
2,93
44,
983
2,92
01,
428
3,53
063
2
Tabl
e 13
: Sci
entif
ic p
roce
dure
s (to
xico
logy
) by
spec
ies
of a
nim
al a
nd ty
pe o
f tox
icol
ogic
al te
st: s
afet
y te
stin
g of
sub
stan
ces
othe
r tha
n ph
arm
aceu
tical
s (c
ontin
ued)
Gre
at B
ritai
n 20
04N
umbe
r of p
roce
dure
s
Spe
cies
of a
nim
alTy
pe o
f tox
icol
ogic
al te
st o
r pro
cedu
reTo
tal
Oth
er re
prod
uctiv
e to
xici
tyIn
eye
sFo
r ski
n Irr
itatio
nFo
r ski
n se
nsiti
satio
nTo
xico
kine
tics
Pyr
ogen
icity
Bio
com
patib
ility
Enz
yme
indu
ctio
n fo
r in
vitro
test
sIm
mun
otox
icol
ogy
Oth
er to
xico
logy
Mou
se-
--
1,88
472
--
-4,
523
293
10,9
20
Rat
14,7
30-
--
397
--
160
-3,
506
37,1
22
Oth
er ro
dent
--
-20
--
--
-24
152
Rab
bit
-71
81,
218
--
--
--
-2,
380
Dog
--
--
--
--
-1
137
Hor
se a
nd o
ther
equ
ids
--
--
--
--
--
-
Oth
er u
ngul
ate
--
--
19-
--
-28
530
4
Bird
--
--
7-
--
-1,
037
1,52
1
Rep
tile
/ Am
phib
ian
--
--
--
--
--
-
Fis
h2,
755
--
-1,
575
--
319
-4,
832
39,5
82
Tot
al17
,485
718
1,21
81,
904
2,07
0-
-47
94,
523
9,97
892
,118
66
Tabl
e 15
: Sci
entif
ic p
roce
dure
s (to
xico
logy
) by
spec
ies
of a
nim
al a
nd ty
pe o
f tox
icol
ogic
al te
st: s
afet
y te
stin
g of
pha
rmac
eutic
als
Gre
at B
ritai
n 20
04N
umbe
r of p
roce
dure
s
Spe
cies
of a
nim
alTy
pe o
f tox
icol
ogic
al te
st o
r pro
cedu
re
Acu
te le
thal
toxi
city
Acu
te le
thal
conc
entra
tion
Acu
te li
mit
setti
ngA
cute
non
- le
thal
cl
inic
al s
ign
Sub
acut
e lim
it-se
tting
or d
ose
rang
ing
Sub
acut
e to
xici
tyS
ubch
roni
c an
d ch
roni
cC
arci
noge
nici
tyG
enet
ic to
xico
logy
(in
clud
es
mut
agen
icity
)
Tera
toge
nici
ty
Mou
se75
,416
-4,
277
4,86
94,
421
5,38
85,
839
7,14
01,
663
971
Rat
--
112
3,40
96,
871
9,80
510
,225
6,02
94,
514
2,39
0
Oth
er ro
dent
102
-63
098
164
198
--
--
Rab
bit
--
-20
922
228
254
--
2,59
2
Cat
--
-6
--
--
--
Dog
--
-16
946
01,
598
1,50
2-
--
Fer
ret
--
--
--
--
--
Oth
er c
arni
vore
--
--
--
--
--
Hor
se a
nd o
ther
equ
ids
--
--
--
--
--
Oth
er u
ngul
ate
--
-2
836
34-
--
New
Wor
ld m
onke
y-
-6
5018
150
64-
--
Old
Wor
ld m
onke
y-
--
4018
568
057
6-
--
Bird
--
--
-51
2-
--
-
Fis
h-
8450
-4,
672
--
--
-
Tot
al75
,518
845,
075
8,85
217
,021
18,3
9518
,494
13,1
696,
177
5,95
3
Tabl
e 15
: Sci
entif
ic p
roce
dure
s (to
xico
logy
) by
spec
ies
of a
nim
al a
nd ty
pe o
f tox
icol
ogic
al te
st: s
afet
y te
stin
g of
pha
rmac
eutic
als
(con
tinue
d)
Gre
at B
ritai
n 20
04N
umbe
r of p
roce
dure
s
Spe
cies
of a
nim
alTy
pe o
f tox
icol
ogic
al te
st o
r pro
cedu
reTo
tal
Oth
er re
prod
uctiv
e to
xici
tyIn
eye
sFo
r ski
n Irr
itatio
nFo
r ski
n se
nsiti
satio
nTo
xico
kine
tics
Pyr
ogen
icity
Bio
com
patib
ility
Enz
yme
indu
ctio
n fo
r in
vitro
test
sIm
mun
otox
icol
ogy
Oth
er to
xico
logy
Mou
se1,
405
-12
462
14,5
14-
-12
152
38,5
8916
5,13
0
Rat
8,10
0-
6-
13,7
70-
-69
-21
,616
86,9
16
Oth
er ro
dent
--
-80
132
--
-25
10,3
2211
,751
Rab
bit
4224
23-
728,
399
44-
-1,
197
13,1
06
Cat
--
--
--
--
-20
26
Dog
--
--
801
--
--
988
5,51
8
Fer
ret
--
--
--
--
-23
23
Oth
er c
arni
vore
--
--
--
--
-6
6
Hor
se a
nd o
ther
equ
ids
--
--
--
--
-48
48
Oth
er u
ngul
ate
--
-8
221
--
-38
42,
407
3,10
0
New
Wor
ld M
onke
y-
--
-15
9-
--
-56
503
Old
Wor
ld M
onke
y-
--
-20
7-
--
-37
52,
063
Bird
--
--
210
--
--
5,29
36,
015
Fis
h-
--
-25
0-
--
-4,
842
9,89
8
Tot
al9,
547
2441
550
30,3
368,
399
4481
561
85,7
8230
4,10
3
67
Tabl
e 16
Sci
entif
ic p
roce
dure
s (to
xico
logy
) by
spec
ies
of a
nim
al a
nd ty
pe o
f tox
icol
ogic
al te
st: o
ther
saf
ety
or to
xico
logy
test
ing
Gre
at B
ritai
n 20
04N
umbe
r of p
roce
dure
s
Spe
cies
of a
nim
alTy
pe o
f tox
icol
ogic
al te
st o
r pro
cedu
reA
cute
leth
alto
xici
tyA
cute
leth
alco
ncen
tratio
nA
cute
lim
it se
tting
Acu
te n
on -
leth
al
clin
ical
sig
nS
ubac
ute
limit-
setti
ng o
r dos
e ra
ngin
g
Sub
acut
e to
xici
tyS
ubch
roni
c an
d ch
roni
cC
arci
noge
nici
tyG
enet
ic to
xico
logy
(in
clud
es
mut
agen
icity
)
Tera
toge
nici
ty
Mou
se8,
395
1,40
04
80-
--
-40
-
Rat
-91
7-
504
506
-11
299
1-
Oth
er ro
dent
73-
--
--
--
--
Rab
bit
--
--
--
--
--
Cat
--
--
--
--
--
Dog
--
--
--
--
--
Oth
er c
arni
vore
--
--
--
--
--
Hor
se a
nd o
ther
equ
ids
--
--
--
--
--
Oth
er u
ngul
ate
--
--
--
--
--
New
Wor
ld m
onke
y-
--
--
--
--
-
Old
Wor
ld m
onke
y-
--
--
--
--
-
Bird
--
--
--
--
--
Rep
tile
/ Am
phib
ian
--
--
--
--
--
Fis
h-
--
--
--
--
-
Tot
al8,
468
2,31
74
584
506
-11
21,
031
-
Tabl
e 16
Sci
entif
ic p
roce
dure
s (to
xico
logy
) by
spec
ies
of a
nim
al a
nd ty
pe o
f tox
icol
ogic
al te
st: o
ther
saf
ety
or to
xico
logy
test
ing (
Con
tinue
d)
Gre
at B
ritai
n 20
04N
umbe
r of p
roce
dure
s
Spe
cies
of a
nim
alTy
pe o
f tox
icol
ogic
al te
st o
r pro
cedu
reTo
tal
Oth
er re
prod
uctiv
e to
xici
tyIn
eye
sFo
r ski
n Irr
itatio
nFo
r ski
n se
nsiti
satio
nTo
xico
kine
tics
Pyr
ogen
icity
Bio
com
patib
ility
Enz
yme
indu
ctio
n fo
r in
vitr
o te
sts
Imm
unot
oxic
olog
yO
ther
toxi
colo
gy
Mou
se40
--
180
1,79
7-
400
-39
912
,996
25,7
31
Rat
296
--
-86
0-
2665
234
6,54
210
,603
Oth
er ro
dent
--
-90
--
--
-29
192
Rab
bit
-61
78-
132
8910
4-
114
961
4
Cat
--
--
--
--
--
-
Dog
--
--
39-
--
-63
102
Fer
ret
--
--
--
--
-18
18
Hor
se a
nd o
ther
equ
ids
--
--
--
--
--
-
Oth
er u
ngul
ate
--
--
--
35-
-10
914
4
New
Wor
ld M
onke
y-
--
--
--
--
--
Old
Wor
ld M
onke
y-
--
--
--
--
602
602
Bird
--
--
--
--
--
-
Rep
tile
/ Am
phib
ian
--
--
--
--
-1,
294
1,29
4
Fis
h-
--
--
--
--
--
Tot
al33
661
7827
02,
828
8956
565
634
21,8
0239
,300
68
819
207
612
–
–
–
191
16
––
–
–
––
–
514
2155
22
58626
Fundamental biological research (all non-toxicology)
Respiratory or cardiovascularNervous or special sensesAlimentary and excretory
Skin and musculo-skeletalReproductiveOther system or system not relevant
Respiratory or cardiovascularNervous or special senses
Alimentary and excretorySkin and musculo-skeletal
ReproductiveImmune system
Other system or system not relevant
Non-toxicology
Toxicology(for pharmaceuticalsafety)
Safety – protection of man, animals or environment
Other uses
Breeding (for nervous and special senses)
69
Table 18a Tree table – scientific procedures involving cats, 2004
8,018
141
21
–
–
32
Fundamental biological research
Respiratory or cardiovascularNervous or special sensesAlimentary and excretory
Skin and musculo-skeletalReproductiveImmune system
–
4939 Other system or system not relevant
10239
Non-toxicology
Toxicology
7,486
10
–
118
951
Applied studies – human medicine, dentistry, veterinary medicine
Respiratory or cardiovascularNervous or special sensesAlimentary and excretory
Skin and musculo-skeletalReproductiveImmune system
16
183
6,208 Other system or system not relevant
1,9155,571
Non-toxicology
Toxicology
147
–
Safety – protection of man, animals or environment (all toxiocology)
Respiratory or cardiovascularNervous or special sensesAlimentary and excretory
Skin and musculo-skeletalReproductive
Other system or system not relevant
––––
147
147 Other uses (all direct diagnosis)
Nervous or special sensesImmune systemOther system or system not relevant
–3
241
244 Direct diagnosis(all non-toxicology)
– Breeding
70
Table 18b Tree table – scientific procedures involving rabbits, 2004
8,517
356
–
193
Fundamental biological research (all non-toxicology)
Respiratory or cardiovascularNervous or special sensesAlimentary and excretory
Skin and musculo-skeletalReproductiveImmune system
–
141 Other system or system not relevant
280
–
–
20
88
Applied studies – all veterinary medicine
Respiratory or cardiovascularNervous or special sensesAlimentary and excretory
Skin and musculo-skeletalReproductiveImmune system
14
21
137 Other system or system not relevant
– Breeding
–
121
5 Safety – protection of man, animals or environment (all toxicology)
Respiratory or cardiovascularNervous or special sensesReproductive
Other system or system not relevant
23743
Non-toxicology
Toxicology (allpharmaceutical work)
–
––
5
7,876
–40
Other uses (all non-toxicology)
Respiratory or cardiovascularNervous or special sensesAlimentary and excretorySkin and musculo-skeletal
Immune system7,836 Other system or system not relevant
407,820
Forensic
Direct diagnosis
–
–
–
16 Education
71
Table 18c Tree table – scientific procedures involving horses and
other equids, 2004
1,035
– Breeding
239 Fundamental biological research (all non-toxicology)
Respiratory or cardiovascularNervous or special sensesAlimentary and excretory
Skin and musculo-skeletalReproductiveImmune system
–
Other system or system not relevant
–118
–
11119
787 Applied studies – human medicine, dentistry, veterinary medicine
Respiratory or cardiovascularNervous or special sensesAlimentary and excretory
Skin and musculo-skeletalReproductiveImmune system
–
Other system or system not relevant
284
503
Non-toxicology
Toxicology (all pharmaceutical work)
10029–
–29
629
– Safety – protection of man, animals or environment
9 Other uses (all direct diagnosis; all non-toxicology)
Respiratory or cardiovascularNervous or special sensesAlimentary and excretory
Skin and musculo-skeletalReproductiveImmune system
–
Other system or system not relevant
–
–
9––
–
72
Table 18d Tree table – scientific procedures involving New World
primates, 2004
3,173
– Breeding
76 Fundamental biological research (all non-toxicology)
Respiratory or cardiovascularNervous or special sensesAlimentary and excretory
Skin and musculo-skeletalReproductiveImmune system
–
Other system or system not relevant8
–
19
8
–41
688
Non-toxicology
Toxicology
2,521 Applied studies – human medicine, dentistry, veterinary medicine
Respiratory or cardiovascularNervous or special sensesAlimentary and excretory
Skin and musculo-skeletalReproductiveImmune system
–
Other system or system not relevant115
1
–
2,134
93178
4392,082
Non-toxicology
Toxicology (nearlyall pharmaceuticalsafety)
575 Safety – protection of man, animals or environment (all toxicology)
Respiratory or cardiovascularNervous or special sensesAlimentary and excretory
Skin and musculo-skeletalReproductive
–
Other system or system not relevant
–
–575
––
1 Other uses
Immune systemOther system or system not relevant
1–
1 Direct diagnosis
73
Table 18e Tree table – scientific procedures involving Old World
primates, 2004
21,736
217 Breeding
Respiratory or cardiovascularOther system or system not relevant
217–
1,869 Fundamental biological research
Respiratory or cardiovascularNervous or special sensesAlimentary and excretory
Skin and musculo-skeletalReproductiveImmune systemOther system or system not relevant
6542
68675
134Non-toxicology
Toxicology
82133
237
1,735
15,327 Applied studies – human medicine, dentistry, veterinary medicine
Respiratory or cardiovascularNervous or special sensesAlimentary and excretorySkin and musculo-skeletalReproductiveImmune systemOther system or system not relevant
8732,750
381139
62367
10,755
13,463Non-toxicology
Toxicology 1,864
2,534 Safety – protection of man, animals or environment (nearly all toxicology)
Respiratory or cardiovascularNervous or special sensesAlimentary and excretorySkin and musculo-skeletalReproductiveImmune systemOther system or system not relevant
3288
–25
–1,218
1,000
2,513Non-toxicology
Toxicology 21
1,789 Other uses (all non-toxicology)
Respiratory or cardiovascularNervous or special sensesAlimentary and excretorySkin and musculo-skeletalReproductiveImmune systemOther system or system not relevant
1,425–
28–
1,728
Forensic
Direct diagnosis
124
320
–Education61
74
Table 18f Tree table – scientific procedures involving rabbits, 2004
914,023
880,209 Rodents (all mice and rats)
Anatomy and developmental biologyImmunologyPharmaceutical R&D
GeneticsMolecular biologyCancer researchOther studies
107,29069,004
94,984269,53447,97456,228
233,647Toxicology1,548
37 Pigs
Anatomy and developmental biologyOther studiesToxicology
37––
114 Birds (all domestic fowl)
GeneticsOther studiesToxicology
114––
1,859 Amphibians
Anatomy, physiologyOther studiesToxicology
1,859––
31,804 Fish
Anatomy and developmental biologyPharmaceutical R&DGenetics
Animal scienceToxicology–
30,061318290
1,135
75
Table 18g Tree table – scientific procedures involving genetically modified
animals, 2004
267,571
227,898 Rodents (all mice and rats)
Anatomy and developmental biologyImmunologyPharmaceutical R&D
GeneticsCancer researchOther studiesToxicology
65,25788,174
12,02227,3838,427
25,625
1,010
338 Rabbits
Pharmaceutical R&DGeneticsOther studies
119–
219
– Toxicology
7 Dogs
Clinical medicineGeneticsOther studies
7–
– Toxicology
–
347 Birds (all domestic fowl)
Anatomy and developmental biologyGeneticsOther studies
–347
– Toxicology
–
1,075 Amphibians
Anatomy and developmental biology1,075
37,906 Fish
Anatomy and developmental biologyPharmaceutical R&DClinical medicine
GeneticsOther studiesToxicology–
–
37,256220
–430
76
Table 18h Tree table – scientific procedures involving animals with a harmful
genetic defect, 2004
Part
B
Tabl
e 19
Pro
ject
lice
nce
hold
ers
and
scie
ntifi
c pr
oced
ures
by
type
of d
esig
nate
d es
tabl
ishm
ent
Gre
at B
ritai
n 20
04
Type
of d
esig
nate
d es
tabl
ishm
ent
Num
ber o
f lic
ence
hol
ders
(1) re
porti
ng c
ount
able
(2) p
roce
dure
sLi
cens
ees
Num
ber o
fP
roce
dure
s
Num
ber o
f pro
cedu
res
Tota
lre
porti
ng
non-
lice
nce
hold
ers(1
)To
tal
Tota
lP
erce
ntag
e1
to
50
51 to
10
010
1 to
20
020
1 to
40
040
1 to
60
060
1 to
80
080
1 to
1,
000
Mor
e th
an
1,00
0
coun
tabl
e(2)
proc
edur
es
only
repo
rting
no
proc
edur
eslic
ense
es
Pub
lic h
ealth
labo
rato
ries
4-
35
12
12
181
726
16,3
080.
6
Uni
vers
ities
, med
ical
sch
ools
433
233
254
268
134
7270
302
1,76
610
704
2,48
01,
201,
982
42.1
NH
S h
ospi
tals
14
34
4-
28
26-
935
26,8
090.
9
Gov
ernm
ent d
epar
tmen
ts40
1114
107
3-
1710
2-
3713
969
,797
2.4
Oth
er p
ublic
bod
ies
5029
3030
1712
1373
254
264
320
449,
920
15.8
Non
-pro
fit-m
akin
g or
gani
satio
ns16
517
188
1-
2893
-31
124
138,
813
4.9
Com
mer
cial
org
anis
atio
ns56
2437
2512
1418
142
328
395
426
951,
315
33.3
Tota
l60
030
635
836
018
310
410
457
22,
587
1694
73,
550
2,85
4,94
410
0
(1)
Som
e lic
ence
-hol
ders
hol
d m
ore
than
one
lice
nce;
thes
e fig
ures
are
com
pile
d by
proj
ect l
icen
ce, n
ot b
y ac
tual
lice
nce-
hold
er.
(2) O
nly
proc
edur
es o
n ad
ult o
r fre
e-liv
ing
anim
als
(incl
udin
g ne
onat
al a
nd ju
veni
le m
amm
als,
and
new
ly-h
atch
ed b
irds)
are
cou
nted
.
D
etai
ls o
f pro
cedu
res
on im
mat
ure
form
s (e
.g. l
arva
e, e
mbr
yos,
fish
fry)
are
col
lect
ed b
ut n
ot c
ount
ed (s
ee in
trodu
ctor
y no
tes,
par
agra
ph 1
2)
Ani
mal
s in
the
wild
invo
lved
in ro
dent
icid
e tri
als
are
also
not
cou
nted
. D
etai
ls (i
f app
licab
le) a
re g
iven
in th
e co
mm
enta
ry.
77
Tabl
e 20
Sci
entif
ic p
roce
dure
s by
spe
cies
of a
nim
al, 1
988-
2004
Gre
at B
ritai
nTh
ousa
nds
of p
roce
dure
sS
peci
es o
f ani
mal
Sci
entif
ic p
roce
dure
s19
8819
8919
9019
9119
9219
9319
9419
9519
9619
9719
9819
9920
0020
0120
0220
0320
04M
ouse
1850
.517
44.9
1,63
6.3
1,69
8.9
1,44
9.0
1,45
7.3
1,47
5.0
1,45
4.9
1,50
2.1
1,51
7.9
1,59
0.8
1,64
1.9
1,60
7.0
1,65
7.7
1,72
0.3
1,81
6.9
1,91
9.1
Rat
860.
488
2.3
891.
588
1.7
833
819.
775
5.9
694.
468
8.8
636.
757
5.9
567.
053
5.0
500.
250
9.6
496.
446
4.7
Oth
er ro
dent
184.
117
1.8
162.
515
213
1.5
138.
214
1.1
134.
212
5.2
103.
393
.181
.471
.561
.660
.048
.137
.5R
abbi
t13
1.8
113.
489
.881
.579
.570
.568
.861
.253
.645
.037
.541
.439
.733
.730
.325
.321
.7C
arni
vore
20.5
21.4
19.3
17.6
17.1
15.3
14.1
15.1
1512
.711
.913
.911
.611
.612
.110
.910
.7U
ngul
ate
38.1
34.8
34.8
31.1
34.4
3332
.255
.360
.360
.068
.063
.663
.037
.457
.375
.575
.1P
rimat
e6.
35.
35.
34.
55
55.
24.
74.
43.
93.
74.
03.
74.
04.
04.
84.
2O
ther
mam
mal
0.4
0.2
0.8
1.3
1.3
2.5
3.2
10.
80.
80.
90.
50.
50.
81.
31.
72.
4B
ird26
9.5
252
245.
622
6.7
220.
311
6.4
189.
614
0.4
113.
912
0.8
141.
210
6.0
124.
212
6.9
138.
312
1.6
105.
3R
eptil
e/A
mph
ibia
n11
.311
.613
.115
1917
.717
.217
.217
.315
.314
.414
.615
.617
.517
.616
.619
.5Fi
sh10
7.5
77.5
108
132
138.
315
2.1
139.
913
1.1
135.
211
9.6
122.
312
2.4
243.
017
1.1
182.
017
4.0
194.
6C
epha
lopo
d(1)
....
....
..0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
Tota
l3,
480.
33,
315.
13,
207.
13,
242.
42,
928.
32,
827.
72,
842.
42,
709.
62,
716.
62,
636.
02,
659.
72,
656.
82,
714.
72,
622.
42,
732.
72,
791.
82,
854.
9
(1)
Oct
opus
vul
garis
, fro
m 1
Oct
ober
199
3.
Tabl
e 21
Sci
entif
ic p
roce
dure
s (to
xico
logy
) by
type
of l
egis
latio
n, 1
995-
2004
Gre
at B
ritai
nTh
ousa
nds
of p
roce
dure
s
Legi
slat
ive
requ
irem
ents
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
UK
requ
irem
ents
onl
y42
.325
.421
.939
.237
.326
.224
.523
.219
.818
.0
Req
uire
men
ts o
f one
EU
cou
ntry
onl
y (1
999
onw
ards
)5.
82.
91.
31.
00.
70.
3
EU
requ
irem
ents
69.6
60.5
54.1
49.3
118.
769
.873
.668
.245
.043
.4
Req
uire
men
ts o
f non
-EU
Cou
ncil
of E
urop
e co
untry
/ies
25.2
10.6
4.6
3.7
0.6
0.6
Oth
er in
tern
atio
nal r
equi
rem
ents
48.0
38.2
24.5
25.7
33.9
29.2
30.6
30.5
22.6
14.0
Join
t req
uire
men
ts (a
ny c
ombi
natio
n of
abo
ve)
399.
944
1.1
415.
035
5.5
247.
524
2.1
255.
129
5.0
284.
830
0.1
Non
-legi
slat
ive
purp
oses
117.
515
5.0
109.
694
.874
.774
.165
.764
.274
.359
.1
Tota
l67
7.2
720.
262
5.1
564.
454
3.2
454.
945
5.5
485.
844
7.7
435.
5
78
Tabl
e 22
Sci
entif
ic p
roce
dure
s by
use
of a
naes
thes
ia, 1
988-
2004
Gre
at B
ritai
nTh
ousa
nds
of p
roce
dure
sLe
vel o
f ana
esth
esia
Sci
entif
ic P
roce
dure
s
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
No
anae
sthe
sia
thro
ugho
ut th
e pr
oced
ure(1
)22
13.1
2094
.92,
205.
42,
223.
71,
960.
01,
792.
51,
796.
61,
751.
417
67.1
1690
.817
23.6
1683
.916
36.3
1551
.116
34.8
1691
.917
10.8
Ana
esth
esia
, with
reco
very
, for
par
t of p
roce
dure
(2)
604.
556
8.7
529.
856
6.9
579.
362
763
2.5
658.
269
4.1
698.
870
2.1
759.
587
3.9
802.
481
0.8
833.
787
4.9
Ter
min
al A
naes
thes
ia(3
)66
2.7
651.
547
245
1.9
388.
940
8.2
413.
330
025
5.4
246.
423
3.9
213.
320
4.5
268.
928
7.2
266.
126
9.3
Tot
al34
80.3
3,31
5.1
3,20
7.1
3,24
2.4
2,92
8.3
2,82
7.7
2,84
2.4
2,70
9.6
2,71
6.6
2,63
6.0
2,65
9.4
2,65
6.8
2,71
4.7
2,62
2.4
2,73
2.7
2,79
1.8
2,85
4.9
(1)
Incl
udes
som
e ex
perim
ents
in w
hich
the
subj
ect o
f the
stu
dy is
the
anae
sthe
tic a
gent
itse
lf.(2
) M
ay b
e lo
cal,
regi
onal
or g
ener
al a
naes
thes
ia.
(3)
At e
nd o
f pro
cedu
re o
r for
who
le p
roce
dure
.
Tabl
e 23
Sci
entif
ic p
roce
dure
s by
type
of d
esig
nate
d es
tabl
ishm
ent,
1988
-200
4G
reat
Brit
ain
Thou
sand
s of
pro
cedu
res
Type
of d
esig
nate
d es
tabl
ishm
ent(1
)19
8819
8919
9019
9119
9219
9319
9419
9519
9619
9719
9819
9920
0020
0120
0220
0320
04
Pub
lic h
ealth
labo
rato
ries
56.4
58.4
73.2
60.2
63.1
51.5
49.2
45.1
35.1
20.0
19.7
25.2
18.4
15.7
16.6
16.3
16.3
Unv
ersi
ties,
med
ical
sch
ools
777.
774
7.6
710.
072
7.8
737.
084
0.6
832.
682
4.1
843.
888
2.1
934.
893
6.1
1,06
9.7
1,00
5.7
1,07
9.8
1,13
0.1
1,20
2.0
Pol
ytec
hnic
s et
c(2)
36.0
29.0
38.1
26.3
32.8
NH
S h
ospi
tals
89.6
92.7
89.6
76.5
80.1
75.8
83.3
94.4
94.3
71.1
75.0
70.1
40.1
28.3
23.1
24.0
26.8
Gov
ernm
ent d
epar
tmen
ts65
.958
.768
.772
.665
.178
.162
.678
.694
.281
.586
.291
.810
0.5
84.6
94.1
72.0
69.8
Oth
er p
ublic
bod
ies
231.
621
7.5
229.
224
4.0
217.
824
0.5
259.
923
5.5
248.
425
9.2
287.
931
2.6
338.
230
9.2
353.
540
7.7
449.
9
Non
-pro
fit m
akin
g or
gani
satio
ns11
5.7
103.
813
2.1
124.
010
4.7
91.4
85.8
102.
611
8.9
117.
711
9.4
119.
511
5.0
161.
415
2.3
136.
313
8.8
Com
mer
cial
org
anis
atio
ns2,
107.
42,
007.
31,
866.
21,
910.
91,
627.
71,
449.
91,
469.
11,
329.
41,
281.
81,
204.
31,
136.
61,
101.
61,
032.
81,
017.
71,
013.
41,
005.
495
1.3
Tota
l3,
480.
33,
315.
13,
207.
13,
242.
42,
928.
32,
827.
72,
842.
42,
709.
62,
716.
62,
636.
02,
659.
42,
656.
82,
714.
72,
622.
42,
732.
72,
791.
82,
854.
9
(1)
For 1
988,
reco
rded
on
the
basi
s of
the
regi
ster
ed o
r des
igna
ted
plac
e w
hich
the
licen
sees
rega
rded
as
thei
r mai
n pl
ace
of w
ork
at th
e tim
e th
e re
turn
s w
ere
issu
ed.
A li
cens
ee m
ay h
ave
com
men
ced
proc
edur
es a
t mor
e th
an o
ne re
gist
ered
or d
esig
nate
d pl
ace
durin
g th
e ye
ar.
For 1
989
onw
ards
, rec
orde
d on
the
basi
s of
the
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79
Table 24 Scientific procedures (non-toxicology) by field of research, 1995-2004Great Britain Thousands of proceduresField of research 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 Psychology 28.4 31.0 38.8 33.1 33.9 106.9 37.9 39.6 38.2 34.7 Pharmaceutical R&D 567.6 504.2 501.5 470.1 481.9 446.7 408.9 365.7 400.4 393.0 Cancer research 262.6 257.8 300.9 293.3 267.0 258.4 268.8 258.1 277.4 275.2 Ecology 14.5 15.2 11.9 13.7 9.1 12.6 19.8 22.1 32.0 35.8 Tobacco -(1) 0.0 0.0 0.0 0.0 0.1 -(1) 0.0 0.0 0.0 Alcohol 3.2 2.2 1.9 0.4 1.2 3.1 3.1 2.3 1.5 0.9 Other 1,156.0 1,185.8 1,155.8 1,284.7 1,320.5 1,432.0 1,428.4 1,559.0 1,594.6 1,679.8
Total 2,032.4 1,996.4 2,010.8 2,095.3 2,113.6 2,259.8 2,167.0 2,246.9 2,344.1 2,419.4
(1) Fewer than 50 procedures
Table 25 Scientific procedures (toxicology) for safety evaluation, 1992-2004Great Britain Thousands of procedures
1992 1993 1994 1995(1) 1996 1997 1998 1999 2000 2001 2002 2003 2004Protection of man, animal or the environment by toxicology or other safety evaluation:
Environmental pollution 59.2 62.9 51.8 35.7 35.7 27.6 34.0 32.3 35.0 38.2 38.2 32.8 29.1 Substances used in agriculture 77 67.3 68.6 65.6 68.8 53.8 55.8 48.1 35.3 41.0 57.8 40.1 28.3 Substances used in industry 91.8 80.2 65.9 85.1 80.4 76.2 58.8 57.6 53.9 52.7 42.3 36.1 33.7
Substances used in the household 2.1 2.2 1.4 1.7 2.6 2.0 1.5 0.3 1.2 0.6 1.0 0.2 0.3 Foodstuffs and food additives 6.1 7.6 8.2 7.4 3.8 7.5 4.0 4.9 6.0 3.5 5.4 8.1 0.9 Cosmetics and toiletries 2.2 3.8 3.5 1.9 2.8 1.3 0.6 0.0 0.0 0.0 0.0 0.0 0.0
Tobacco 0.2 0 0.03 - (2) .. .. .. .. .. .. .. .. .. Alcohol research 1.1 7.3 9.1 - (2) .. .. .. .. .. .. .. .. .. Other safety evaluation 19 10.6 8.7 .. .. .. .. .. .. .. .. .. ..
Pharmaceutical - safety, efficacy, ADME and residue .. .. .. 333.2 365.8 311.2 284.4 269.6 203.8 204.8 220.1 202.3 211.8 Pharmaceutical - quality control .. .. .. 83.8 84.3 77.8 74.0 85.6 70.9 72.2 74.5 78.3 92.3 Other purposes .. .. .. 62.7 76 67.7 51.4 44.7 48.8 42.5 46.4 49.8 39.3
Total 258.6 242 217.2 677.2 720.2 625.1 564.4 543.2 454.9 455.5 485.8 447.7 435.5
.. No comparable figures are available.(1) Where series have been discontinued or a new series started, it is because there is little or no direct comparability between figures from previous years and the current year.(2) In previous years, research on tobacco and alcohol was included, for historical reasons, in the "safety" categories. From 1995 onwards, they are in the non-toxicology tables.
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Table 26 Scientific procedures by primary purpose, 1995-2004
Great Britain Thousands of procedures
Primary purpose of the procedure 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004
Fundamental biological research 841.2 884.8 829.4 894.9 803.8 872.8 778.7 864.3 832.9 880.9Applied studies - human medicine or dentistry 1,073.3 1,012.2 945.4 847.3 836.2 739.0 689.9 669.9 693.7 671.9 veterinary medicine 199.2 144.1 160.1 181.3 169.6 190.7 182.2 175.0 150.7 156.4Protection of man, animals or the environment 209.2 219.7 201.0 170.4 153.3 161.2 153.6 185.6 151.4 114.1Education 7.1 6.7 5.9 6.3 5.5 4.7 4.6 4.3 3.7 2.7Training 1.7 1.7 1.6 1.6 1.4 1.3 1.2 1.0 0.9 0.9
Forensic enquiries 0.1 0.1 0.1 0.1 0.1 - (1) - (1) - (1) - (1) - (1)
Direct diagnosis 65.0 55.8 55.5 52.0 47.8 45.3 34.5 41.3 55.8 45.3Breeding 312.7 391.5 437.0 505.8 639.1 699.6 777.8 791.2 902.6 982.6
Total 2,709.6 2,716.6 2,636.0 2,659.7 2,656.8 2,714.7 2,622.4 2,732.7 2,791.8 2,854.9
(1) Fewer than 50 procedures
Table 27 Scientific procedures by primary purpose and genetic status, 1995-2004
Great Britain Thousands of procedures
Primary purpose of procedure 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004
Normal animal Fundamental biological research 713.1 724.8 656.2 664.1 621.5 653.2 560.9 584.7 563.4 560.2 Applied studies 1,219.2 1,101.1 1,043.8 969.4 937.9 857.7 810.5 780.6 779.7 756.4 Safety 208.9 219.0 200.8 170.1 153.3 161.1 153.5 185.4 151.3 114.0 Other uses 73.0 64.2 62.8 59.9 54.7 51.3 40.1 46.7 59.6 48.3 Breeding 53.5 72.2 83.0 89.2 126.7 152.8 179.8 165.5 194.9 194.5 Total 2,267.7 2,181.3 2,046.6 1,952.7 1,894.1 1,876.1 1,744.8 1,762.8 1,748.9 1,673.4Animal with harmful genetic defect Fundamental biological research 53.8 43.9 43.3 57.5 55.1 54.5 46.8 63.8 47.7 68.7 Applied studies 40.7 41.0 50.1 42.7 42.9 50.8 44.6 37.7 40.7 46.6 Safety 0.2 0.7 0.3 - - - (1) - 0.1 (1) Other uses (1) (1) 0.2 (1) 0.1 0.1 0.1 (1) 0.4 0.1 Breeding 131.9 148.0 142.8 159.1 152.9 151.5 155.3 158.4 190.0 152.2 Total 226.6 233.7 236.6 259.3 251.0 256.9 246.8 259.9 278.8 267.5Genetically modified animal Fundamental biological research 74.3 116.2 129.9 173.2 127.2 165.1 171.0 215.8 221.9 252.0 Applied studies 12.7 14.2 11.7 16.5 24.9 21.2 17.0 26.6 24.0 25.4 Safety 0.1 - - 0.3 - 0.1 0.1 0.2 0.1 0.1 Other uses 1.0 - (1) (1) (1) (1) (1) (1) 0.4 0.6 Breeding 127.2 171.2 211.1 257.6 359.5 395.4 442.7 467.3 517.7 635.9 Total 215.3 301.6 352.8 447.6 511.6 581.8 630.8 710.0 764.1 914.0All animals Fundamental biological research 841.2 884.8 829.4 894.9 803.8 872.8 778.7 864.3 832.9 880.9 Applied studies 1,272.6 1,156.3 1,105.6 1,028.7 1,005.7 929.7 872.1 844.9 844.4 828.3 Safety 209.2 219.7 201.0 170.1 153.3 161.2 153.6 185.6 151.4 114.1 Other uses 74.0 64.2 63.0 59.9 54.9 51.4 40.3 46.7 60.4 49.0
Breeding 312.6 391.5 437.0 505.8 639.1 699.6 777.8 791.2 902.6 982.6
Total 2,709.6 2,716.6 2,636.0 2,659.7 2,656.8 2,714.7 2,622.4 2,732.7 2,791.8 2,854.9
(1) Fewer than 50 procedures
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82
APPENDIX A
General system of control under the Animals (Scientific Procedures) Act 1986
Introduction
1. The Animals (Scientific Procedures) Act 1986 put in place a rigorous system of controls on scientific work on living
animals, including the need for both the researcher and the project to be separately licensed; stringent safeguards on
animal pain and suffering; and general requirements to ensure the care and welfare of animals.
2. Operation of the Act is not a devolved responsibility in Great Britain, the Home Office administering the legislation
in England, Scotland and Wales. The Act is separately administered in Northern Ireland.
Scope of the Act
3. The Act controls any experimental or other scientific procedure applied to a ‘protected animal’ which may have the
effect of causing that animal pain, suffering, distress or lasting harm. Such work is referred to in the Act as a ‘regulated
procedure’. ‘Protected animals’ are defined as all living vertebrate animals, except man, plus one invertebrate species,
Octopus vulgaris. The definition extends to foetal, larval or embryonic forms that have reached specified stages in their
development. Under the Act an animal is regarded as ‘living’ until “the permanent cessation of circulation or complete
destruction of its brain”. Procedures carried out on decerebrate animals are also subject to the controls of the Act.
4. The definition of a regulated procedure encompasses some breeding of animals with genetic defects; production of
antisera and other blood products; the maintenance and passage of tumours and parasites; and the administration for a
scientific purpose of an anaesthetic, analgesic, tranquilliser or other drug to dull perception. Killing an animal requires
licence authority in certain circumstances.
5. The controls of the 1986 Act do not extend to procedures applied to animals in the course of recognised veterinary,
agricultural or animal husbandry practice; procedures for identification of animals for scientific purposes, if this causes
no more than momentary pain or distress and no lasting harm; or clinical tests on animals for evaluating a veterinary
product under authority of an Animal Test Exemption (issued under the Medicines Act 1968).
6. Two kinds of licence are required for all scientific work controlled by the Act. The procedures must be part of a
programme of work authorised by a project licence and the person applying the regulated procedures must hold a
personal licence. No work may be done unless the procedure, the animals used and the place where the work is to be
done are specifically authorised in both project and personal licences.
Personal Licences
7. A personal licence is the Home Secretary’s endorsement that the holder is a suitable and competent person to carry
out specified procedures on specified animals, under supervision where necessary. Applicants must be over 18 and are
required to give details of their qualifications, training and experience. Those who have not previously held a Home
Office licence need the endorsement of a sponsor (normally someone in a senior position at the applicant’s place of
work). Satisfactory completion of an accredited training course is also required before a personal licence is issued.
8. During 2004, 2,156 personal licences were granted and 2,392 were revoked. On 31 December 2004 there were
14,113 active licences. Personal licences continue to be in force until revoked, but they must be reviewed at least every
five years.
Project Licences
9. A project licence is granted when the Home Secretary considers that the use of living animals in a programme of
work, for a purpose permitted by the Act, is justified and the methods proposed appropriate. In deciding whether and
on what terms to authorise the project, the likely adverse effects on the animals used must be weighed against the
potential benefits (to humans, other animals or the environment) which are expected to accrue from the work. Adequate
consideration must also have been given to the feasibility of using alternative methods not involving living animals. The
holder of a project licence undertakes overall responsibility for the scientific direction and control of the work and is
responsible for making the statistical returns on which this publication is based. New project licence applicants are
required to complete an accredited training course before the licence is granted.
10. When making an application for a project licence, the applicant nominates, and the Home Office assigns, an overall
severity banding for the project. There are three possible severity bandings: mild, moderate and substantial. A fourth
band, unclassified, is used for procedures where the animal is decerebrate or used under terminal anaesthesia – i.e. the
animal is anaesthetised before the procedure starts, is kept anaesthetised throughout the course of the procedure and is
killed without recovering consciousness.
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11. It is not possible to lay down hard and fast rules about how the severity should be assessed. It depends not only upon
the amount of suffering caused, but also the duration, the number of animals and what action is taken to reduce suffering,
such as the use of anaesthesia or early endpoints. The overall severity is used in weighing the likely adverse effects on
the animals against the benefits likely to accrue, as required by section 5(4) of the Act.
12. The following table details the number of project licences which were active on 31 December 2004, the number
granted during 2004 and the number revoked during 2004 (normally either at the licence holder’s request or because the
licence had run the maximum allowed term of five years). The total figures are subdivided into severity bandings.
Project licences
Severity band In force on Granted during 2004 Revoked during 200431 December 2004
Number % Number % Number %
Mild 1,116 38 214 37 254 40
Moderate 1,641 56 334 58 346 54
Substantial 56 2 12 2 14 2
Unclassified 86 3 15 3 20 3
Total 2,899 575 634
Designation of premises
13. Except where otherwise authorised in a project licence (e.g. for field work at a specified place and time), any place
where work is carried out under the Act must be designated as a scientific procedure establishment. Since January 1990,
establishments which breed certain types of animal (mouse, rat, guinea-pig, hamster, rabbit, dog, cat and primate) for
use in scientific procedures (‘breeding establishments’), and establishments which obtain such animals from elsewhere
and supply them to laboratories (‘supplying establishments’) must hold a certificate of designation. Quail (Coturnixcoturnix) was added to the list of species specified in Schedule 2 of the Act in 1993, and ferrets, gerbils, genetically
modified pigs and genetically modified sheep were added to the list in 1999. Designated establishments are required to
nominate a person to be responsible for the day-to-day care of animals and a veterinary surgeon to advise on their health
and welfare.
14. The following table details the number of certificates of designation which were in force on 31 December 2004, the
number granted during 2004 and the number revoked during 2004. The figures are subdivided for different types of
establishment.
Certificates of Designation
Establishment type In force on 31/12/2004 Granted during 2004 Revoked during 2004
Commercial concern 82 0 3
Higher education 84 2 1
Quango 30 0 1
Government 10 0 1
Non-profit 13 0 0
NHS hospital 5 0 0
Public health 3 0 0
Total 227 2 6
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15. Of the 227 certificates of designation active on 31 December 2004, 223 were registered as user establishments, 141
as breeding establishments and 68 as supplying establishments. These figures add up to more than the total number of
establishments because a single establishment may be represented in more than one of the categories: for example, an
establishment may be registered as both a breeder and user of animals.
Guidance and Codes of Practice
16. In addition to these annual statistics, the Act requires the Home Secretary to publish and lay before Parliament
guidance on the operation of the controls of the Act and codes of practice as to the care and accommodation of animals
and their use in regulated procedures. These and other documents have been published and can also be found at the
Home Office website http://www.homeoffice.gov.uk/comrace/animals/index.html. These documents include:
• Guidance on the operation of the Animals (Scientific Procedures) Act 1986 (latest version 2000; HC 321);
• Code of practice for the housing and care of animals used in scientific procedures (1989; HC 107);
• Code of practice for the housing and care of animals in designated breeding and supplying establishments (1995;
HC 125);
• Code of Practice for the Humane Killing of Animals under Schedule 1 to the Animals (Scientific Procedures)
Act 1986 (1997; HC193);
• Guidance on the Conduct of Regulatory Toxicology and Safety Evaluation Studies;
• Code of Practice for the housing and care of animals in designated breeding and supplying establishments;
Supplement: Ferrets and Gerbils (laid before Parliament on 7 November 2001);
• Information document on the handling of infringements under the 1986 Act (placed on website in June 2002);
• Supplementary Guidance to applicants for project licences: projects for educational purposes (September 2002);
• “Points to Consider” document entitled “Non-Rodent Selection in Pharmaceutical Toxicology” (produced by the
Association of the British Pharmaceutical Industry in conjunction with the Home Office in August 2002);
• Home Office response to the report of the Expert Group on Efficient Regulation (October 2002);
• Home Office response to the Report of the House of Lords Select Committee on Animals in Scientific
Procedures (Cm 5729 – January 2003);
• Inter-Departmental group on the 3Rs minutes;
• Inter-departmental concordat on data sharing.
Education and training
17. The Animals (Scientific Procedures) Act 1986 imposes clear responsibilities on persons with specific roles in
relation to the care and use of animals in scientific procedures. These are elaborated further in the Home Office guidance
on the operation of the Act (HC 321, The Stationery Office, 2000) as mentioned above. As the roles differ, it follows
that the education and training required before assuming these responsibilities will differ:
• personal licence holders are responsible for the welfare of animals on which they carry out regulated procedures;
applicants will be granted licences only if adequately trained to take on this responsibility and they will usually
be required to work under supervision initially;
• project licences will be issued only to persons with appropriate qualifications to direct a programme of work
which is well-justified and takes account of all reasonable possibilities for reducing the number of animals used,
refining the procedures to reduce suffering and replacing animal procedures with alternatives which do not
involve protected animals;
• holders of certificates of designation have responsibility not only for ensuring that the fabric and staffing of
designated places are maintained to appropriate standards but also for ensuring that reasonable steps are taken
to prevent unauthorised procedures being carried out and that adequate training facilities are available for all
animal users.
18. Training programmes for applicants for personal and project licences are described in Appendix F of the Guidance
on the operation of the Animals (Scientific Procedures) Act 1986 (2000; HC 321). All training programmes are
accredited under a scheme recognised by the Home Office. Accreditation seeks to achieve common and high standards
for licensee training which will facilitate free movement of licensees within the UK and Europe as well as ensuring high
standards in the use of animals for scientific purposes.
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19. Satisfactory completion of an accredited course prior to application for a personal licence has been a requirement
under Home Office policy since 1 April 1994. A similar requirement has applied to new applicants for project licences
from 1 April 1995.
20. During 1995, mandatory training for Named Veterinary Surgeons was also introduced. Training requirements for
Named Animal Care and Welfare Officers were introduced in 2004.
The acquisition and use of primates
21. During 1996, following recommendations made by the Animal Procedures Committee, new measures on the
acquisition and use of non-human primates were introduced:
• the use of wild-caught primates was banned except where exceptional and specific justification can be
established;
• specific justification must be made for the use of old world (as opposed to new world) primates;
• specific justification must be made for the use of old world primates in toxicological procedures of more than
mild severity;
• approval for the acquisition of primates from overseas will only be given if the conditions at the breeding or
supplying centre are acceptable to the Home Office; and
• each batch of animals acquired from overseas, or other non-designated, sources must be separately authorised
and the transport arrangements approved by the Home Office.
Animals Scientific Procedures Division
22. Towards the end of 2003 the Animals Scientific Procedures Division was formed within the Home Office, to link
more closely together under one senior manager the Animal Procedures Licensing, and Policy Development, sections,
the Animals (Scientific Procedures) Inspectorate (which retains its independent advisory role) and, for certain
management purposes, the Secretariat of the Animal Procedures Committee. The Division therefore deals with all Home
Office business relating to the Animals (Scientific Procedures) Act 1986.
23. Administrative staff, operating the licensing system on behalf of the Secretary of State, process applications for new
licences and certificates; process amendments to existing authorities; and revoke or vary licences and certificates as
necessary. It is these staff in the Animals Scientific Procedures Division (not Inspectors nor the Animal Procedures
Committee) who grant, refuse, vary, revoke and suspend licences and certificates for the Secretary of State. The
licensing team also administers the collection of annual fees from designated establishments and of annual statistical
returns of procedures from project licence holders.
24. On 31 December 2004, the administrative licensing section had a total complement of 23 staff and managers. The
licensing work was carried out at five regional offices: Cambridge, Dundee, London, Shrewsbury and Swindon.
25. Policy staff in the Animals Scientific Procedures Division are the primary source of advice to Ministers on issues
relating to the Act, including the preparation of responses to Parliamentary Questions and correspondence from MPs
and the public about the use of animals in scientific procedures.
The Inspectorate
26. The Act provides for the appointment of Inspectors and describes their duties. Inspectors hold either a medical or
veterinary qualification.
27. Inspectors assess all applications for new licences or amendments to existing licences in detail and advise the Home
Secretary on how to ensure that only properly justified work is licensed. When assessing research proposals, the
Inspector ensures that full consideration is given to alternatives, not only the replacement of procedures with others
which do not use animals but, where animals have to be used, the reduction of the number of animals used and the
refinement of procedures to minimise pain and suffering. These are known as the 3Rs. Inspectors carry out visits,
mainly without notice, to establishments designated under the Act to inspect the premises and to ensure that the
establishment’s controls are adequate and that the terms and conditions of the licences issued under it are being
observed.
28. Inspectors also advise the Home Secretary on policy matters connected with the operation of the Act and they are
available to give advice to licensees and other personnel working under the Act.
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29. At 31 December 2004, there were 30 inspectors in post. The distribution of inspectors was:
Chief Superintending
Inspector Inspectors Inspectors
London 1 1 27
Cambridge 1 24
Dundee 2 25
Shrewsbury 24
Swindon 25
Total 1 4 25
30. In 2004, the Inspectorate carried out 3,888 visits in addition to meeting demands for advice and assessment in
connection with the issue and amendment of licences and the formulation of policy. Of these visits, 2,682 were for the
purpose of inspection of designated establishments and work in progress. Well over 50 per cent of the visits to
designated departments were unannounced. The remaining 1,206 visits were for the purpose of maintaining scientific
or professional skills, representing the Home Office or furthering Home Office policy.
Performance against published target
31. Since April 2002, the Licensing Section and the Inspectorate have been committed to process at least 85 per cent of
applications for project licences within 35 working days.
32. Data for 2004 indicate that the average processing time for all applications was 22 working days; 81 per cent of
completed and signed project licence applications were processed within the 35 working days target, although many
applications were actually turned around in significantly less time. It is expected that this performance will improve
further once a new IT system currently under development is in place.
The Animal Procedures Committee
33. The 1986 Act established the Animal Procedures Committee (APC), which has the duty of advising the Home
Secretary on matters concerned with the Act and his functions under it. The Home Secretary may refer matters to the
Committee, but the APC is also free to consider topics of its own choosing. The Committee is required in its
consideration of any matter to have regard both to the legitimate requirements of science and industry and to the
protection of animals against avoidable suffering and unnecessary use in scientific procedures. Each year, the
Committee makes a report to the Home Secretary, which is laid before Parliament and published.
34. The Act requires that, excluding the Chairman, the Committee must have a minimum of 12 members; one must be
a lawyer and at least two thirds must be medical practitioners, veterinary surgeons or have qualifications or experience
in a biological subject. At least half of the members must not have held a licence under the Act within the last six years.
The Home Secretary must also ensure that animal welfare interests are adequately represented.
35. More information about the Committee and its work can be found on its website at http://www.apc.gov.uk/
Recent developments
36. In May 2004, Caroline Flint announced the creation of a new national centre for replacement, refinement and
reduction of animals in research with an initial budget of £660k. At the same time, she announced that the Home Office
would transfer its research budget (£250k) to the new centre when current commitments have been honoured.
37. In June 2004 the Inter-Departmental Group on the 3Rs reported to Ministers on its review of the Inter-Departmental
Concordat on Data Sharing. The Concordat is aimed at minimising requirements for animal tests by ensuring that the
regulators concerned encourage and overcome barriers to data sharing between animal users. The review concluded that
the concordat is comprehensive in its coverage of the issues relevant to the successful implementation of data sharing
and identified a number of areas in which encouraging progress had been made since it was announced in 2000. The
review also concluded that the concordat provided a sound framework for further action and that no changes were
required to its provisions. A further review of the implementation of the Concordat was agreed in two years time.
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38. In July 2004, Caroline Flint announced the outcome of the review of section 24 of the Animals (Scientific
Procedures) Act 1986 – the so-called ‘confidentiality clause’ – which prohibits the disclosure by Home Office Ministers
and officials of confidential information relating to the use of animals in scientific procedures other than in the discharge
of their functions under the 1986 Act. Caroline Flint reported that the conflicting views expressed about section 24 in
the course of the review had shown it to be a complex and contentious issue that did not lend itself to a decision that
would satisfy all those with an interest. In particular, those representing the views of many in the scientific community,
while supporting other means of progressing openness and transparency about the use of animals in scientific research,
had expressed significant concern about the potential impact of repealing section 24 and had urged strongly that it be
retained. In the circumstances, the review concluded that section 24 should be retained for the time being. However, the
future repeal of section 24 was not ruled out and a further review of section 24 would be carried out in two years time.
39. In December 2004 the Home Office began publishing, on the Home Office website, abstracts of project licences
granted under the Animals (Scientific Procedures) Act 1986. This implemented a commitment given in the
Government’s reply to the report of the House of Lords Select Committee on Animals in Scientific Procedures to publish
abridged details of project licences. Further abstracts will be published as and when new licences are granted.
40. Work on revising Directive 86/609/EEC, which the Animals (Scientific Procedures) Act 1986 transposes into UK
legislation, announced in 2003, continued during 2004. Four technical expert working groups set up by the European
Commission provided preliminary advice on what a revised Directive might incorporate, and four technical issues have
been referred to the Animal Welfare Committee of the European Food Standards Agency (EFSA) for consideration and
advice. The Commission will produce a consultation document in the light of the advice received from EFSA.
Summary of infringements
41. In the published statistics for 2000, details were given of new streamlined procedures for handling infringements.
Action on 28 infringements was completed under these procedures in 2004.
Class One infringements
42. These involve minor breaches of licence or certificate conditions, which are not potential criminal offences, have no
aggravating circumstances and no disputed facts.
43. Three Class One infringements were dealt with in the reporting period. Two occurred in academic establishments,
and one in a Quango. All three were discovered by the inspectorate.
Class Two infringements
44. These may include potential criminal offences, but are cases where it is clear from the circumstances that
prosecution, variation of licence/certificate conditions or revocation action would not be appropriate. Formal
admonition is generally the action taken against those responsible.
45. Twelve Class Two infringements were dealt with in the reporting period. Academic establishments and Quangos
were involved in five each, and commercial establishments in two. Nine were self-reported and three were discovered
by the inspectorate.
Class Three infringements
46. These are the more serious cases, where training/re-training, variation, suspension or revocation of
licences/certificates, or referral to the police for possible prosecution are considered. Any case where animal welfare
may have been compromised must be treated as a Class Three infringement, and all such cases are referred to the Head
of the Animal Procedures Licensing Section for consideration.
47. Thirteen infringements in this category had action completed on them in the reporting period.
48. Nine were reported by licensees to the Home Office, and four were discovered and reported by the Inspectorate.
49. A total of twelve establishments had Class Three infringements reported. Academic establishments were involved
in seven, commercial establishments in three, and Quangos in the remaining two.
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Nature of Class Three infringements
50. As in previous years, the nature of the infringements varied in severity. In four cases a regulated procedure was
applied to animals without appropriate project licence authority in breach of section 3(b) of the 1986 Act, and in one
case without appropriate personal licence authority and to animals that had previously completed a series of regulated
procedures, without the authority for their further use in breach of sections 3(a) and 14(3) of the Act. In one case
regulated procedures were applied to animals that had previously completed a series of regulated procedures, without
the authority for their further use in breach of section 14(3); in two cases there was inadequate supervision of animals;
in one case severity limits were exceeded; in three cases animals were not being maintained to the required standards
as set out in the Home Office Code of Practice for the Housing and Care of Animals in Designated Breeding and
Supplying Establishments; and in one case animals were not being maintained to the required standards as set out in the
Home Office Code of Practice for the Housing and Care of Animals used in Scientific Procedures.
Action taken
51. It should be borne in mind when reading the following paragraphs that any infringement case may involve more than
one personal or project licence holder.
52. As a result of these infringements, 21 licence holders were admonished; seven were required to attend relevant
modules of an accredited training course; three holders of certificates of designation were required to review the systems
of control at their establishments in order to prevent recurrence; and 1 non-licensee was sent a letter of censure.
53. Those admonished include personal and project licence holders, and holders of certificates of designation. They also
include those who were additionally required to undergo training.
Animals (Scientific Procedures) Act 1986
Return of procedures by project for 2004
Dear Project Licence Holder
This form sets out the arrangements for the 2004 annual return of statistics of regulated procedures conducted under the Animals(Scientific Procedures) Act 1986. It should be used to record procedures that were started during 2004. If you are not the projectlicence holder for the project licence number displayed above, please return the form to the address below with an explanatory note.
If you are the project licence holder please:-
� read and answer question 1 under SECTION 1. If the answer to the question is NO simply sign and date the form, giving acontact telephone number and email address, and return it to the address below. However if the answer is YES, please readthe rest of this letter, accompanying notes, and code lists carefully before completing the form in black ink.
� complete the form with care; this is a computer input document.This should avoid queries at a later date.
PLEASE NOTE CAREFULLY THE CODING INSTRUCTIONS.THERE ARE SOME WORKED EXAMPLES ON PAGES 9 & 10.
� discard any old coding instructions, and use only those instructions supplied with this form.
� after satisfying yourself that it has been completed accurately, sign and date the form, giving a contact telephone number andemail address, and return it by 31 JANUARY 2005, to:-
Home OfficeRoom 511, Allington Towers19 Allington StreetLONDON SW1E 5EB
It is a requirement of the Animals (Scientific Procedures) Act 1986 that this return is completed, and it should be returned
to us by 31 January 2005 at the latest. Failure to comply constitutes a breach of the Act and may be considered as a
Class 2 infringement.
� retain a copy of this return in case of queries.
Thank you in advance for your care and attention.
Animals Scientific Procedures DivisionScience and Research Group
SECTION 1 (to be completed by the Project Licence Holder)
� under normal circumstances the form will not be accepted unless you, the project licence holder, sign SECTION 1. If this isnot possible due, for example, to sickness or other unavoidable leave of absence, a note from the signatory to explain the circumstances should be attached.
1. Have any procedures under the Animals (Scientific Procedures) Act 1986 under the project shown above been started during 2004?
Enter "Y" for YES or "N" for NO
2. If NO please sign below and return the form. If YES please complete SECTION 2 and check that the form has been completed in accordance with the instructions. Then sign below and return the form.
Declaration: I am satisfied that the information required by the Secretary of State under the conditions of my project licence hasbeen supplied accurately in accordance with the instructions given.
Signature of project licence holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Name of signatory in BLOCK LETTERS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Contact telephone number . . . . . . . . . . . . . . . . . . . . . . . Email address . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
OFFICIAL USE ONLY
Serial Number
Project licencenumber
Establishmentcode
89
01 02 03 04Section 2Select the appropriate codes byreferring to the enclosed notes.
Row
1
Row
2
Row
3
Row
4
Row
5
Row
6
Row
7
Row
8
Row
9
Row
10
Row
11
Row
12
Row
13
Row
14
Row
15
SpeciesWhich animals were used in the procedure?
CITESIs animal on the CITES list?
(see notes)
Stage of DevelopmentWhat was the stage of development of the animal?
Genetic StatusWere the animals genetically abnormal?
SourceFrom where were the animals obtained?
AnaesthesiaWere the animals anaesthetised?
NMBAWas an NMBA administered?
Primary PurposeWhat was the primary purpose of the procedure?
Body SystemWhat was the primary target body system for the procedure?
ALL WORK OTHERTHAN TOXICOLOGY
Field of Research Use List B
TOXICOLOGYPurpose
Use List A
Production
Use List BType of Test
Use List A
Techniques
Use List BLegislative Requirements
Use List A
Number of ProceduresEnter the total number of procedures for each column
Number of animals used for the first timeEnter the total number of animals used for the first time
in regulated procedures
Number of animals Reused for the first time this yearEnter the total number of animals reused for the first time this year
in regulated procedures (see Notes)If no animals were reused this should be set to zero
PPL NO: FORM SERIAL NO:
90
05 06 07 08 09 10 11 12 13 14 15
FORM SERIAL NO:PPL NO:
91
16 17 18 19 20 21 22 23 24 25 26
FORM SERIAL NO:PPL NO:
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GENERAL NOTES
1. It is a condition of every project licence that the project licence holder must make a return before31 January of all regulated procedures on living animals commenced during each year. Only onereminder of this obligation will be sent.
2. Information subsequently published by the Home Office will not identify the work of any individualestablishment or project licence holder.
3. If you hold more than one project licence, you will receive a separate return of procedures form foreach licence. The project licence number is shown on the front of the form. Please take care toensure that the work of personal licensees appears on the return of procedures form carrying thecorrect number. It is the responsibility of project licence holders to ensure that the work of all personal licensees performing regulated procedures on their project is included in their returns.
4. The form SHOULD NOT be used to notify changes in personal details. Such changes should benotified separately to your regional office or to:
APLS, Room 511Home OfficeAllington Towers19 Allington StreetLONDON SW1E 5EB
NOTES ON COMPLETING SECTION 2
5. Before completing SECTION 2 please study the section carefully and read the notes on Code Listsfor each ROW. Be sure that you understand what is meant by:
- CITES listed species, ROW 2
- Schedule 2 listed species, ROW 5
- Procedure, ROW 13
You may find it helpful to refer to paragraphs 2.6 to 2.33 of the Home Office Guidance on the Operationof the Animals (Scientific Procedures) Act 1986 (Published in March 2000 by HMSO, reference HC321)before completing this section. This Guidance is also available atwww.homeoffice.gov.uk/comrace/animals/legislation.html
6. If you have carried out any work using harmful mutant or genetically modified animals, you mustread the whole of Annex A of the notes (on Page 8) carefully.
7. Complete SECTION 2 column by column in line with the sequence shown by the arrows. For eachentry in a column (i.e. each box) select the most appropriate code from the code list for that ROW.
8. Do not enter more than one code in any box. Where a different set of codes is needed to describefully the use of different groups of animals in a particular procedure, complete as many columns asnecessary. If a mistake is made and alterations are necessary, strike out the whole column andcomplete a fresh one.
9. Each completed column should contain a unique combination of codes and record all theprocedures for any animal or group of animals of the same species which are described by thatparticular combination of codes.
10. If your project requires more than 26 columns to describe it, please photocopy and completeSECTION 2 and attach the additional sheets to your return, making clear that they are additionalsheets and that the project licence number appears on them.
11. Forms not completed in accordance with the guidance notes may be returned to the licence holderfor clarification. Acceptance of the form in compliance with standard condition 10 of the licence willNOT be recorded until a properly completed form is received in the Home Office.
12. Please consult your Inspector if you are uncertain how to complete the form correctly.
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ROW 1 : SPECIES
Select the appropriate code from the list below.
MAMMAL
R0 Use this code for rodenticide field trials only. There is no needto complete the rest of the column.You must provide a covering letter giving estimates of thenumbers of each species which may have under gone pain,suffering, distress or lasting harm during the field trials.
R1 MouseR2 RatR3 Guinea pigR4 HamsterR5 GerbilR9 Other rodent (please append a note indicating species used)L1 RabbitC1 CatC2 Dog - beagleC3 - greyhoundC4 - other including cross-bred dogsC5 FerretC9 Other carnivore (please append a note indicating species used)U1 Horse, donkey and cross-bred equidsU2 PigU3 GoatU4 SheepU5 CattleU6 DeerU7 CamelidU9 Other ungulate (please append a note indicating species used)
PrimateP1 - prosimian
- new world monkeyP2 - marmoset, tamarinP3 - squirrel, owl or spider monkeyP4 - other new world monkey
- old world monkeyP5 - macaqueP6 - baboonP7 - other old world monkey
- apeP8 - gibbonP9 - great ape J9 Other Mammal(please append a note indicating species used)
BIRDT1 Domestic fowl (Gallus domesticus)T2 TurkeyT3 Quail (Coturnix coturnix)T4 Quail (spp. other than C. coturnix)T9 Other bird (please append a note indicating species used)
REPTILED1 Any reptilian species (please indicate species used)AMPHIBIANM1 Any amphibian species (please indicate species used)FISHF1 Any fish species (please indicate species used)CEPHALOPODF5 Octopus vulgaris
ROW 2 : SPECIES
Animals of endangered species listed in Appendix 1 of the
Convention on International Trade in Endangered Species of
Flora and Fauna (CITES) or in Annex C.1 to the Council
Regulation (EEC) 3626/82(a) are subject to special controls andinformation is required on their use. Most species and strains of ani-mals used in the laboratories are not included in the CITES lists.Please consult your Inspector for further information.
Select the appropriate code from the list below.
1 the specifies used in this procedure is listed in Appendix 1 orAnnex C.1. (please give both common and Latin name for species)
0 the species is not so listed.
Some examples of CITES codes:0 Common marmosets; macaca spp except M. silenus1 Cotton top tamarins (Saguinus oedipus);
some birds of prey such as Peregrine falcon (Falco peregrinus)
ROW 3 : STAGE OF DEVELOPMENT
Select the appropriate code from the list below.
1 Adult animal, free-living (including neonatal and juvenilemammals and newly-hatched birds).
2 Larval/embryonic/foetal animal. DO NOT COUNT THESEANIMALS – ENTER "0" IN ROWS 13, 14 AND 15.
ROW 4 : GENETIC STATUS
Select the most appropriate code from the list below
1 Normal animal2 Animal with harmful genetic defect (e.g. harmful mutants)3 Genetically modified animal (e.g. transgenic, knock-out).
Important guidance on coding and counting of harmful mutants
or genetically modified animals is given in Annex A.
ROW 5 : SOURCE OF ANIMALS
Schedule 2 of the Act lists the following species: mouse, rat, guinea-
pig, hamster, gerbil, rabbit, dog, cat, ferret, primate and quail
(Coturnix coturnix).
Also: pigs, if genetically modified
sheep, if genetically modified
Enter:
0 If the species is NOT listed in schedule 2.
For schedule 2 species enter:-
1 If the animals were acquired from within own designatedestablishment.
2 If the animals were acquired from another designated estab-lishment in the UK (e.g. a university; commercial breeder).
3 If the animals were acquired from non-designated sources inthe UK.
4 If the animals were acquired from other countries within theEU other than the UK (See list at LIST A, ROW 12 below).
5 If the animals were acquired from member countries of theCouncil of Europe which are parties to convention ETS 123(excluding EU member states). (See list below).
6 If the animals were acquired from other sources.
Non-EU ETS 123 countries (code 5 above) as at 1 January 2004
Cyprus Switzerland
Norway Turkey
ROW 6 : ANAESTHESIA
Select the most appropriate numeric code from the list below.
0 No anaesthesia throughout the procedure.
Include procedures without anaesthesia which end by aSchedule 1 method of killing even if this consisted of ananaesthetic overdose. Use this code also for the study ofpotential anaesthetic agents.
1 General anaesthesia with recovery.
Used at any stage of the procedure irrespective of other usesof anaesthesia.
2 Local or regional anaesthesia.
Used at any stage of the procedure.
3 General anaesthesia without recovery.
Used at the end of a procedure which did not otherwiseinvolve anaesthesia. (See note below).
4 General anaesthesia without recovery.
Used throughout the procedure.
NOTE
If the animal was killed by a method listed in Schedule 1 of the Actusing an overdose of an anaesthetic agent, this was not part of theregulated procedure and should not be recorded as such.
CODE LISTS
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ROW 7 : NEUROMUSCULAR BLOCKING AGENTS
Select the appropriate code from the list below.
0 No use of neuromuscular blocking agents (NMBA).
1 NMBA used during the procedure at some stage. (Associatedcodes for row 6 will usually be 1, 3 or 4.)
ROW 8 : PRIMARY PURPOSE OF THE PROCEDURE
Select the appropriate code from the list below.
1 Fundamental biological research:studies of normal or abnormal structure or function of livingorganisms, organs, tissues, cells or other systems (includingfundamental studies in toxicology).
2 Applied studies – human medicine or dentistry:research, development or quality control of products or appli-ances including toxicological evaluation and safety or efficacytesting.
3 Applied studies – veterinary medicine:research, development or quality control of products or appli-ances including toxicological evaluation and safety or efficacytesting.
4 Protection of man, animals or environment bytoxicological or other safety or environmental evaluation (exclud-ing medical or veterinary products or appliances). This categoryis intended to cater for toxicological work which is not relatedeither to fundamental research or to the solution of medical orveterinary problems as such. Ecological studies may be includedhere with the appropriate codes in Rows 10-12: A codes for toxi-cological testing or B codes for other investigative studies.
5 Education
6 Training:use of animals in acquisition of manual skills is permitted inmicrosurgery training only.
7 Forensic enquiries:human or veterinary.
8 Direct diagnosis:procedures for specific detection of human or veterinarypathogens or production of diagnostic reagents.
9 Breedingof harmful mutants or genetically modified animals.Before selecting this code please read the guidance inAnnex A. If using this code row 11 must be B61, B62, or B64.
ROW 9 : BODY SYSTEM
Select the code from the list below which most closely describes theprimary target body system for the procedure.01 Respiratory02 Cardiovascular03 Nervous (work directed towards central or peripheral nervous
systems other than the special senses)04 Special Senses (sight, hearing, smell, taste)05 Alimentary (including liver) and Excretory06 Skin07 Musculo-skeletal08 Reproductive09 Immune and reticulo-endothelial10 Other system (where the target was a single system not list-
ed)11 Multiple systems (where more than one system was of pri-
mary interest)12 System not relevant (where the system or systems affected
were not predictable or not relevant)
ROW 10, 11 & 12
Codes from EITHER list A OR LIST B should be used to complete
these rows within a column. A mixture of A and B codes within a
column is not permitted.
Use list A if the primary purpose of the procedure described in thecolumn was a toxicological or other regulatory or safety purpose(including efficacy, quality control, ADME).
Use list B for any other primary purpose.
LIST A, ROW 10
TOXICOLOGY OR OTHER SAFETY OR EFFICACY EVALUATION
If the procedure was carried out for a toxicological or other safety-related purpose (including efficacy, quality control, or other regulatorypurpose), select the most appropriate code from the list below.
A01 Environmental pollutionA02 Substances used in agricultureA03 Substances used in industryA04 Substances used in the household (see example (col. 2) on page 9)A05 Food additives other than those administered in food for
health purposesA06 Foodstuffs other than additivesA07 Cosmetics and toiletries – finished productsA08 Cosmetics and toiletries – ingredients
Pharmaceutical safety/efficacy evaluationA11 Safety testingA12 Efficacy testingA13 Quality controlA14 Absorption, Distribution, Metabolism and Excretion (ADME)
and residue studies
Other purposeA21 Fundamental research in toxicologyA22 Tobacco safety testing (inducing alternatives)A23 Safety/Efficacy testing of medical appliances or devicesA24 Method development or validationA25 Other toxicological purpose
LIST A, ROW 11
TYPE OF TEST OR PROCEDURE
If the procedure was carried out for a toxicological or other safety-relatedpurpose (i.e. you have used a code from A01– A25 in Row 10), select thecode from the list below which describes the procedure most accurately.The OECD test references are examples and are given only for guidance.A30 Acute quantitative lethal toxicity test (LD50) (OECD 401).
Please append a note if the test was conducted as anLD50 test according to OECD 401.
A31 Acute quantitative lethal concentration tests (LC50) (OECD403 or 203).
A32 Acute limit-setting (e.g. OECD 401), or dose-ranging lethal tox-icity tests.
A33 Acute oral toxicity test (e.g. OECD 420, OECD 423, OECD425). Includes such tests as Fixed Dose Procedure, AcuteToxic Class method, Up and Down method, Maximum Non-Lethal Dose or Maximum Tolerated Dose.
A34 Subacute limit-setting (e.g. OECD 407) or dose-ranging toxici-ty test (usually 14 to 28 days duration)
A35 Subacute quantitative toxicity test (e.g. OECD 407, 410). (usu-ally 14 to 28 days duration).
A36 Subchronic and chronic toxicity tests (e.g. OECD 408, 409,411, 413, 452) (tests for 90 days or more)
A37 Carcinogenicity tests (e.g. OECD 451)A38 Genetic toxicology tests (e.g. OECD 474, 475) – includes
mutagenicity tests and the Micronucleus test.A39 Teratogenicity testsA40 Other reproductive toxicity tests, including multigeneration studiesA41 Tests for clinical signs in eyes (e.g. OECD 405)A42 Tests for skin irritation (e.g. OECD 404)A43 Tests for skin sensitisation (e.g. OECD 406). Please indicate
if you have used either the Guinea pig Maximisation Testor the Buehler Assay (OECD406).
A44 Toxicokinetics (e.g. OECD 417)A45 Pyrogenicity testsA46 Biocompatibility testsA47 Enzyme induction for in vitro testsA48 Immunotoxicology testsA50 Other toxicology tests – these other tests may include collection of
normal tissues such as blood for in vitro work, and investigativeprocedures not compatible with other codes.
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LIST A, ROW 12
LEGISLATIVE REQUIREMENTS
If the procedure was carried out for a toxicological or other safety-related purpose (i.e. you have used a code from A01 – A25 in row10), select the code from the list below which most closely describesthe legislative requirements for which the procedure was performed.Note that "legislative requirement" includes a requirement imposedby a product or manufacturing licence of the country concerned.
Where a test was intended to satisfy both UK and other requirementsand involved more animals than the UK minimum requirements twocolumns should be used to describe the tests. The first columnshould record the number of animals used to satisfy UK requirementsusing Code A91 in Row 12 and the second column should show theremainder using the most appropriate Code (A92 or A93) in Row 12.
A91 Procedures performed to meet UK legislative requirementsonly
A92 Procedures performed to meet national legislation specific toonly one EU member state, excluding the UK (see list below).
A93 Procedures performed to meet EU legislative requirementsincluding European Pharmacopoeia
A94 Procedures performed to meet member country of Council ofEurope (excluding EU) legislation (see list below)
A95 Procedures performed to meet legislative requirements ofother countries e.g. USA, Japan
A96 Any combination of A91-A95 requirements
A97 Toxicity tests carried out for purposes other than meeting leg-islative requirements
Safety testing to satisfy HSE regulations or similar legislation in othercountries should be classified as a legislative requirement choosingfrom codes A91-A96 as appropriate.
COUNTRY LIST FOR CODE A92 ABOVE AND CODE 4 IN ROW 5
(EU countries other than the UK) as at 1 January 2004
Austria Germany Netherlands
Belgium Greece Portugal
Denmark Irish Republic Spain
Finland Italy Sweden
France Luxembourg
COUNTRY LIST FOR CODE A94 ABOVE
(Council of Europe nations other than EU) as at 1 January 2004
Albania Hungary Russian Federation
Andorra Iceland San Marino
Armenia Latvia Slovakia
Azerbaijan Liechtenstein Slovenia
Bulgaria Lithuania Switzerland
Croatia Malta Former Yugoslav
Cyprus Moldova Rep.of Macedonia
Czech Republic Norway Turkey
Estonia Poland Ukraine
Georgia Romania
LIST B, ROW 10
FUNDAMENTAL AND APPLIED STUDIES OTHER THAN
TOXICOLOGY
If the procedure was carried out for a purpose other than toxicologyor safety evaluation, select the code from the list below which bestdescribes the primary field of research.
Any of these studies (e.g. clinical medicine, clinical surgery, pharma-ceutical R and D, cancer research) may apply to either veterinary ormedical science – the appropriate code for the primary purpose ofthe animal use would have been given in Row 8.
B01 Anatomy and developmental biologyB02 PhysiologyB03 BiochemistryB04 Psychology/BehaviourB05 PathologyB06 ImmunologyB07 MicrobiologyB08 ParasitologyB09 PharmacologyB10 Pharmaceutical Research and Development except anti-can-
cer agents (code B17)B11 TherapeuticsB12 Clinical medicineB13 Clinical surgery including technique developmentB14 DentistryB15 GeneticsB16 Molecular biologyB17 Cancer Research including therapyB18 NutritionB19 ZoologyB20 Botany and plant pathologyB21 Agricultural animal science not included in codes aboveB22 Ecology and environmental studies other than toxicology or
other safety evaluationB23 Animal welfare studies not included in the codes aboveB24 Other purpose – if you use this code you must provide a
separate note describing the procedure
B31 Tobacco researchB32 Alcohol research
Use these codes for research on tobacco or alcohol or their constituents.Do not use these codes for use ofthese substances as pharmacologicaltools or standards
}
REMEMBER: Do not mix codes from lists Aand B in a column.
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LIST B, ROW 11
PRODUCTION AND BREEDING
If you used a code from B01 to B32 in Row 10, select a code from thelist below which applies to the procedure described in this column.
Production of biological materials
B50 Ascites model for production of monoclonal antibodiesB51 Production and maintenance of infectious agentsB52 Production and maintenance of vectors (e.g. insects)B53 Production and maintenance of neoplasmsB54 Initial immunisation for subsequent in vitro or in vivo
production of monoclonal antibodiesB55 Production of polyclonal antibodiesB56 Production of other biological material (e.g. plasma, tissues)
BreedingYou should read Annex A on pages 8 and 9, as well as the example on page 10 to ensure correct use of the following codes.
B61 Animals used to generate founder genetically modifiedanimals for novel transgenic lines, chimeras or clones – thisincludes normal animals used in such programmes, e.g.superovulation, vasectomy, pseudopregnant recipients, as wellas those animals culled as not being of the appropriate geneticstatus, but which have undergone regulated biopsy procedures.
B62 Genetically modified animals generated by recognisedhusbandry methods for the maintenance of a breeding colony.This may include normal animals (which have undergoneregulated biopsy procedures) produced by using heterozygoteparents, as well as animals with a fate as set out in Annex A,paragraph 2, attached.
B63 Genetically modified animals used in research programmes,where they underwent regulated procedures other than thoserequired for a breeding programme, i.e. where the primarypurpose was NOT breeding, i.e. Row 8 = 1-8. Normal or wild-type animals used as controls in such research and alsosubject to regulated procedures should be coded as 1 in Row4 and codes B50-B56, or B79 as appropriate, in this list.
B64 Harmful mutant animals generated by recognised husbandrymethods for maintenance of breeding colonies. This mayinclude animals with a fate set out in Annex A, paragraph 2,attached. Normal animals, which have not undergone anyother regulated procedures, do not need to be accounted for –see Annex A, 1(i). Where harmful mutant animals have beencrossbred with a GM line, the offspring should be reported asGM.
B65 Harmful mutant animals used in research programmes,where they underwent regulated procedures other than thoserequired for a breeding programme, i.e. where the primarypurpose was NOT breeding, i.e. Row 8 = 1-8. Normal or wild-type animals used as controls in such research and alsosubject to regulated procedures should be coded as 1 in Row4 and codes B50-B56, or B79 as appropriate, in this list.
Other
B79 None of the above
LIST B, ROW 12
TECHNIQUES OF PARTICULAR INTEREST
If you used a code from B01 to B32 in Row 10, select a code from thelist below which applies to the procedure described in this column.
B91 Direct interference with any part of the organs of specialsense including the brain centres
B92 Direct injection of micro-organisms or material suspected ofcontaining micro-organisms into the brain
B93 Other direct physical interference with the brainB94 Induction of psychological stress integral to the procedure B95 Use of aversive training stimuliB96 Exposure to ionising radiation at doses intended to produce a
potentially adverse effect on the animalB97 Inhalation – DO NOT USE FOR FISHB98 Thermal injury B99 Physical trauma B00 None of the above
where the study of such injury or traumawas the purpose of the procedure}
IMPORTANT NOTES ON RE-USE
ROWS 13 and 14
If your records show that the number of procedures carried out
(Row 13) exceeds the number of animals used for the first time
(Row 14), then animals have been re-used, as defined by Section
14 of the Act. Standard condition 5 of the project licence requires
that there is express authority for the re-use of animals. Re-use
will be authorised in your project licence either in sub-section
(iv) or (vii) of a protocol in Section 19(b), OR as an additional con-
dition to your project licence.
ROW 15This row is needed to assess re-use as required by the Council
of Europe. Report the number of animals re-used for the FIRST
time during the reporting year. This will include animals used for
the first time in the reporting year which have been re-used, as
well as those animals used for the first time in previous years,
and re-used for the first time during the reporting year.
For example: an animal is bled three times per year for the
collection of normal blood.
In the first year the animal is used, it would be counted once in
Row 14, three procedures would be recorded in Row 13, and one
procedure in Row 15 for the first re-use.
In subsequent years, the figures would be Row 13=3, Row 14=0 and
Row 15=1. See also the worked example in column 3 on page 9.
ROW 13 : NUMBER OF PROCEDURES CARRIED OUT ON
ANIMALS
Each separate use of one animal counts as one procedure. Onlyprocedures started during the year should be included. Procedureswhich have been reported in returns for previous years and havecontinued into the current reporting year should not be included.
Do not include foetal, larval or embryonic animals: enter '0' in row13 for these animals. Also enter '0' in Row 13 if you have entered 'R0'in Row 1.
ROW 14 : NUMBER OF ANIMALS USED FOR THE FIRST TIME
Where animals are used in more than one separate procedure (i.e.reuse; see below) only the first use counts towards the total which youshould enter in row 14. This is true whether or not the second and/orsubsequent procedures are described in the same column or anyother columns of the return or on another return.
If there is no re-use, the number of animals entered here will be thesame as in row 13. See worked examples on pages 9 and 10.
If you have entered '0' in row 13, enter '0' in row 14.
Re-use. In general, if the same animal is being used as a matter ofnecessity, as in a series of regulated procedures for a particularpurpose, this is not regarded as re-use. For example, where it isnecessary to know how an animal responds to drugs A, B and Cbefore interpreting its response to drug D, there is no choice and thesuccessive use of the animal constitutes a single series of procedureswithout re-use. By contrast, if the procedures are unrelated or adifferent animal could equally well have been chosen for the secondor subsequent procedures, use of the same animal is regarded as re-use. For example, if, by choice, repeated samples of normal bloodwere taken from a rabbit, but each sample could equally as well havecome from a fresh rabbit, this would count as re-use and should beentered as such.
ROW 15 : NUMBER OF ANIMALS RE-USED FOR THE FIRST
TIME IN THE CURRENT YEAR
Please read the guidance on re-use in the instructions above.
Please record here animals re-used for the first time this year,regardless of whether the first use of the animal was this year or anyprevious year.
If there is no re-use the number recorded here must be 0.
If you have entered 0 in Row 13, then this row must also be 0.The sum of the values in Rows 14 and 15 must not exceed the
value in Row 13.
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ANNEX A
Coding and counting of animals with abnormal genetic constitution
To avoid the risk of double counting, the encoding of animals with harmful genetic defects (harmful mutants) and genetically modifiedanimals (e.g. transgenic animals, knock-outs, chimeras and clones) (Row 4, codes 2 or 3) differs, depending on whether their usewas limited to breeding procedures or whether they were subsequently used in other regulated procedures under project licenceauthority.
Mating is a regulated procedure under the terms of the Act if it may result in the creation of either harmful mutant or geneticallymodified animals which are protected by the Act. However the parents do not themselves suffer potential harm during mating.Consequently, it is only the offspring which should be counted for the return of procedures in accordance with these notes.
The harmful mutant or genetically modified parents (used only for breeding) should be reported once only, when they are originallycreated (see Section 3 below for imported animals). Genetically normal parents which have undergone no other regulated proceduresshould not be counted for the purposes of the annual statistics.
(i) For animals with harmful genetic defects (harmful mutants), only those animals in which the defect actually manifests itself (asdenoted by genetic testing, coat colour or marking, or by direct observation) should be reported, using code 2 in Row 4. Normalanimals which have been produced from the breeding programme and have NOT been subjected to any other regulatedprocedure (such as blood sampling), should not be reported.Where harmful mutant animals have been crossbred with agenetically modified line, the offspring should be reported as genetically modified.
(ii) For genetically modified animals:
– all animals used in procedures (e.g. vasectomy, superovulation, implantation) for the development of genetically modifiedanimals should be recorded in Row 4 as code 1 (normal) or 3 (genetically modified), as appropriate: in Row 8 as code 9; inRow 11 as code B61. Note: Animals coded as B61 in Row 11 should always be coded 9 in Row 8.
– subsequently, during breeding of the established genetically modified line, only those animals identified as geneticallymodified should be recorded as such using code 3 in Row 4. Normal animals from the breeding programme should berecorded as code 1 in Row 4 only if further regulated procedures were carried out on those animals, e.g. biopsy procedures.
1. Animals which are used under project licence authority, for a purpose other than breeding.
These should be encoded and enumerated later when the necessary information is available on their primary use in a procedureother than breeding using the appropriate code from Row 8. This may mean that these animals are not reported in the year in whichthey are born.
Coding in all rows should reflect the further use in a regulated procedure, rather than the initial breeding:
(i) when their use for a scientific purpose consisted of what would otherwise have been non-regulated procedures (i.e. non-invasive observations, killing by a Schedule 1 method for dissection or in vitro study), then codes B62 or B64 should be used asappropriate in Row 11, and codes 1-8 in row 8.
(ii) if the use was a regulated procedure within the same project as that under which the animal was bred, the coding should reflectthe particular purpose and use for that animal. For example, use of nude mice for maintenance of a neoplasm would be coded 2in Row 4, code 1 – 8 in Row 8, and B53 in List B, Row 11. If there is no other suitable code in Row 11, use codes B63 or B65as appropriate.
(iii) likewise, if an animal was transferred to a project other than the one under which it was bred, it should be reported there andthe coding should reflect the purpose for which the animal was used in the project to which it was transferred. It should NOT beentered in the return of the project under which it was bred. In these circumstances it may be that animals are born under thebreeding licence at the end of one calendar year, but not moved to the using project licence until the following year such thatthey will only be returned in the year in which they are used.
The assumption underlying these arrangements is that the objectives of procedures in (i), (ii) and (iii) above require the use of theanimals with harmful genetic defects or genetic modifications; consequently they have not been re-used in procedures, as defined bySection 14 of the Act, and the recording and returning arrangements should reflect this. However any further use in regulatedprocedures beyond that described above may constitute re-use and would require appropriate coding and counting to reflect this(such re-use, of course, requires appropriate project licence authority – see "Important notes on re-use" at top right of Page 7).
2. Animals bred under project licence authority, but not used in further regulated procedures
The fact that such animals have been produced should be included in the returns using code 9 in Row 8 and appropriate codes fromthe B list in Rows 10 to 12. In Row 11, codes B62 and B64 should be used. In addition to the animals described at 1(i) above, B62and B64 codes will include those animals which, for the reasons set out below, were not used for any specific scientific purposebeyond being bred:
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(i) they died or were humanely killed as a result of the harmful genetic defect or the genetic manipulation;
(ii) they died or were humanely killed as a result of other causes, e.g. disease;
(iii) they were humanely killed as surplus to requirements;
(iv) they were retained for breeding;
(v) they were exported live to a place outside the jurisdiction of the Act (for which special permission must have been obtained fromthe Home Office).
3. Live animals from non-designated sources, usually imported, for use in breeding programmes authorised by project
licence
Specific authority must have been obtained from the Home Office for such acquisition.
(i) If these animals were used only in non-harmful breeding procedures (as parents only) to procedure a new colony, they shouldbe recorded once in the year in which they were obtained using code 9 for Row 8, and codes B62 or B64, as appropriate, in ListB, Row 11.
(ii) Animals which go on to be used in other regulated procedures should be coded for that use as noted in Section 1 of Annex Aabove.
N.B. HARMFUL MUTANT AND GENETICALLY MODIFIED ANIMALS SHOULD BE REPORTED ONLY ONCE IN THEIR LIFETIME.
Examples (counting; re-use; and use of certain toxicology codes):
Column 3
A Company uses cats for the study of feline nutrition. The regulated procedures do not involve general anaesthesia and the projectlicence authorises re-use of the animals. Last year 40 new cats were purchased and used. This year 50 more cats were purchasedfrom the same UK designated source and used. In the experiment recorded in Column 3 all 90 cats were used for a feeding studywith subsequent blood sampling. The 50 cats purchased this year were used for the first time. The 40 cats used last year were re-used in this experiment for the first time during this new calendar year.
Column 1 2 3Row 1 R2 R1 C1Row 2 0 0 0Row 3 1 1 1Row 4 1 1 1Row 5 2 2 2Row 6 1 0 0Row 7 0 0 0Row 8 2 4 3Row 9 11 12 05Row 10 A14 A03 B18Row 11 A50 A35 B79Row 12 A96 A93 B00Row 13 15 40 90Row 14 15 40 50Row 15 0 0 40
Column 1
Fifteen 8-week-old rats of normal genetic status were purchased from a commercialbreeder in the UK for the following experiment. This required surgical implantation ofvascular cannulae with recovery from general anaesthesia, without the use ofneuromuscular blocking agents. Subsequently the animals were dosed with a potentialdrug for cancer therapy and three timed blood samples are taken from the cannulae fora pharmacokinetic study. Finally the animals were killed by perfusion of fixative undergeneral anaesthesia. The whole series of six interventional techniques were carriedout for a particular purpose and were covered by the description in a single 19(b)protocol sheet of the project licence.
Column 2
40 genetically normal, six week old mice were purchased from a commercial breederin the UK for use in a sub-acute quantitative toxicity test (28 days study) to providedata on a household product for a client of a contract toxicology company. The 28 daystudy was needed to fulfil the requirements for safety evaluation of the product duringthe manufacturing process when material needs to be moved in bulk, i.e. the testing isrequired under the regulations relating to the safety of substances used in industry forproduction within the EU, and consequently row 10 should be coded A03 (industry)and not A04 (household).
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Further examples - breeding procedures
Columns 4 - 10
At the beginning of the calendar year, there are 10 pairs of genetically modified mice in a breeding colony for fundamentalimmunological research. The colony is maintained using heterozygote parents as homozygous offspring must be killed at five weeksof age due to an adverse phenotype. The breeding pairs had been included in the previous year’s return for use in breedingprocedures. During the course of the year 300 offspring are produced. All of these animals undergo local anaesthesia to remove thetip of the tail for genotyping.
Assuming a perfect Mendelian distribution, 75 animals are found to be homozygous and are killed by 5 weeks of age using a Schedule1 method of killing. However, the tissues from 50 of the animals were used for in vitro cell culture and further relevant research(Column 4). The remaining 25 animals are returned for use in the breeding programme only (Column 5). Seventy five animals arefound not to express the genotype of interest and were culled by a Schedule 1 method of killing (Column 6). Of the remaining 150heterozygote animals, 30 are retained as the future breeding nucleus (Column 7). Fifty are used in further procedures involvinggeneral anaesthesia with recovery but without neuromuscular blockade for dosing and sampling under procedures in the projectlicence under which they were bred (Column 8). Another 50 are killed by perfusion under terminal general anaesthesia in accordancewith the project licence (Column 9). Ten animals are moved to the project licence of a collaborator in the UK in order to set up theirown breeding colony. Ten animals are exported, with appropriate Home Office authority, to a collaborator in another country (Column10).
Note: the 20 animals of the original 10 pairs are not counted for the current calendar year. Also the 10 animals which were moved tothe UK collaborator are not counted, as they should be returned under the project licence to which they have moved.
Column 4 5 6 7 8 9 10Row 1 R1 R1 R1 R1 R1 R1 R1Row 2 0 0 0 0 0 0 0Row 3 1 1 1 1 1 1 1Row 4 3 3 1 3 3 3 3Row 5 1 1 1 1 1 1 1Row 6 2 2 2 2 1 2 2Row 7 0 0 0 0 0 0 0Row 8 1 9 9 9 1 1 9Row 9 09 09 09 09 09 09 09Row 10 B06 B06 B06 B06 B06 B06 B06Row 11 B62 B62 B62 B62 B63 B62 B62Row 12 B00 B00 B00 B00 B00 B00 B00Row 13 50 25 75 30 50 50 10Row 14 50 25 75 30 50 50 10Row 15 0 0 0 0 0 0 0
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APPENDIX C
ERRATA IN 2003 PUBLISHED TABLES
Since the publication of the annual statistics for the year 2003, a number of errors have come to light. The corrected
tables in their entirety will be found on the website for the 2003 publication:
http://www.official-documents.co.uk/document/cm62/6291/6291.htm
Table 8
The penultimate column of table 8, which describes procedures not related to production, showed incorrect values. The
correct values are shown, in italics, in the excerpt below. The “Other” column in this table includes all procedures
related to breeding, together with any other procedures not specifically related to production.
Table 8: non-toxicological procedures for production, 2003 (excerpt)
Species of animal Other Total
Mouse 1,495,306 1,627,459
Rat 323,514 353,233
Other rodent 32,182 34,999
Rabbit 3,007 7,788
Cat 1,217 1,234
Dog 1,409 2,068
Ferret 663 1,078
Other carnivore 1,476 1,476
Horse and other equids 3,161 8,795
Other ungulate 42,432 63,355
New World monkey 737 817
Old World monkey 423 441
Other mammal 1,737 1,737
Bird 38,695 103,254
Reptile/Amphibian 8,727 15,106
Fish 117,719 121,222
Total 2,072,405 2,344,062
Table 12 Toxicology procedures by species and type of toxicological test
In the 2003 publication, the row for rabbits was missing from the first page of the table only. The column totals for the
first page were also incorrect. However the second page and the total column and the grand total all appeared correctly.
A revised, corrected, table appears on the site for the 2003 publication, as mentioned above.
Table 13 Toxicology procedures by species and type of test, for safety testing of substances other than
pharmaceuticals
The row for “horse and other equids” did not appear in this table. However, no procedures were reported for these
species for these kinds of tests in 2003 and the row, had it appeared, would have been entirely zero.
Printed in the UK by The Stationery Office Limited
on behalf of the Controller of Her Majesty’s Stationery Office
ID 184128 12/05
PREVIOUS RETURNS
Annual publications giving detailed figures for scientific procedures under the Animals (Scientific Procedures) Act 1986
were published (by HMSO) as “Statistics of scientific procedures on living animals” as follows:
Year Command
Paper
2003 Cm 6291
2002 Cm 5886
2001 Cm 5581
2000 Cm 5244
1999 Cm 4841
1998 Cm 4418
1997 Cm 4025
1996 Cm 3722
1995 Cm 3516
1994 Cm 3012
1993 Cm 2746
1992 Cm 2356
1991 Cm 2023
1990 Cm 1574
1989 Cm 1152
1988 Cm 743
1987 Cm 515
Detailed figures for experiments on living animals under the Cruelty to Animals Act 1876 were published (by HMSO)
as “Statistics of experiments on living animals” as follows:
Year Command
Paper
1986 Cm 187
1985 Cmnd 9839
1984 Cmnd 9574
1983 Cmnd 9311
1982 Cmnd 8986
1981 Cmnd 8657
1980 Cmnd 8301
1979 Cmnd 8069
1978 Cmnd 7628
1977 Cmnd 7333
Less detailed information about experiments on living animals for the years prior to 1977 was published in the form of
a “Return to an Address of the Honourable the House of Commons”.
Feedback
The Home Office would welcome comments from users on how well this publication meets their
needs, and will consider any suggestions for improving it in future years. Comments and
suggestions must be sent to the address below by 31 March 2006 if they are to be taken into
account in time for the next publication (covering procedures started in 2005).
Comments should be sent to:
Science and Research Group,
1st Floor, Seacole Block,
Home Office,
2 Marsham Street,
LONDON SW1P 4DF
or email: [email protected]
ISBN 0-10-167132-6
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